DEVICE: Oscilla (05713557000076)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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37503 | Tone audiometer |
An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.
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Active | false |
41188 | Speech audiometer |
An electroacoustic device designed to measure the hearing threshold of a patient by presenting words of increasing or decreasing intensity through headphones, which the patient is required to recognize and repeat, to establish the hearing capacity of the patient and to determine if a hearing deficit exists.
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Active | false |
41187 | Tone audiometer, automated |
An electroacoustic device designed to be used in a clinical setting to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. A computer or microprocessor in the device automatically produces tones that sweep the audiometric scale and controls tone intensity and frequency. The device also records the patient's responses and may display calculated hearing thresholds. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.
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Obsolete | false |
41184 | Tone audiometer, manual |
An electroacoustic device designed to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. Changes in tone intensity, frequency, and the recording of patient responses are all performed manually.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EWO | Audiometer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -10 and 50 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 50 and 120 KiloPascal |
Handling Environment Temperature: between 15 and 35 Degrees Celsius |
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 80 and 120 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d83e41a3-6c5c-4e4a-a9b4-b4d7ad592917
August 03, 2023
6
September 21, 2016
August 03, 2023
6
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4586742622
support@oscillahearing.com
support@oscillahearing.com