DEVICE: Sentiero Desktop Screening (04260223141478)
Device Identifier (DI) Information
Sentiero Desktop Screening
100497-US1
In Commercial Distribution
PATH medical GmbH
100497-US1
In Commercial Distribution
PATH medical GmbH
Sentiero Desktop Screening Set US1
Sentiero Desktop Screening Set Tymp with IPSI Reflex
Content:
1. Sentiero Desktop (Tymp Screening) AN100434-SB
2. USB data cable AN100418
3. Probe EP-TY long AN100188-US
4. FW Screening Tymp class 2 AN100560
5. Software label printer AN100414
6. Accessory box for Tymp probe AN100587
7. Accessory box Sentiero (Grason) AN100734
8. Power supply Senti / Sentiero Desktop FW7662M AN100524
9. Power supply adapter Senti / Sentiero Desktop USA/-UK/-EU/-AUS. AN100525-USA/-UK/-EU/-AUS
10. Test cavity tymp AN100549
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Evoked-potential audiometer | An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EWO | Audiometer |
GWJ | Stimulator, Auditory, Evoked Response |
ETY | Tester, Auditory Impedance |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K133012 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
332c20c5-651a-49fb-a962-5a466e2879f1
July 06, 2018
3
August 31, 2016
July 06, 2018
3
August 31, 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
[?]
No Customer Contact currently defined