DEVICE: Audioscan (B161RM500SL0)

Device Identifier (DI) Information

Audioscan
RM500SL
In Commercial Distribution

Etymonic Design Incorporated
B161RM500SL0
HIBCC

1
244780581 *Terms of Use
The RM500SL is a portable hearing aid analyzer intended to be used by hearing care professionals such as audiologists and hearing aid specialists to verify the electro-acoustic performance of a hearing aid connected to a standard earphone coupler or while worn on the ear of the end user.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Audiometric/hearing aid tester An electroacoustic device intended to be used for the evaluation of hearing loss (audiometer function), the evaluation of hearing aids while worn to assure optimal amplification (real-ear measurement), and/or for other hearing aid analysis (functions as the hearing aid analyser to check its proper function when this is being fitted to the patient). It typically consists of a test box and a control unit that connect to a computer that runs application software to provide results and graphics (which may be stored in a database). The control unit may also be connected to other manufacturer's test boxes, or run as an audiometer or real-ear-measurement instrument without the test box.
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FDA Product Code

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Product Code Product Code Name
ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 20 and 50 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 81 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

7a544816-4d15-4362-895f-1fdc220f0af5
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B161RM500SL3 1 B161RM500SL0 In Commercial Distribution Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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No CLOSE

Customer Contact

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15192683313
support@audioscan.com
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