Audioscan
GUDID B161RM500SL3
The RM500SL is a portable hearing aid analyzer intended to be used by hearing care professionals such as audiologists and hearing aid specialists to v
Etymonic Design Incorporated
Audiometric/hearing aid tester| Primary Device ID | B161RM500SL3 |
| NIH Device Record Key | 7a544816-4d15-4362-895f-1fdc220f0af5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Audioscan |
| Version Model Number | RM500SL |
| Company DUNS | 244780581 |
| Company Name | Etymonic Design Incorporated |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com | |
| Phone | 15192683313 |
| support@audioscan.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 81 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B161RM500SL0 [Primary] |
| HIBCC | B161RM500SL3 [Package] Contains: B161RM500SL0 Package: Carton [1 Units] In Commercial Distribution |
FDA Product Code
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Audioscan]
| B161VERIFITVF20 | Verifit VF-2 |
| B161RM500SL3 | The RM500SL is a portable hearing aid analyzer intended to be used by hearing care professionals |
| B161AXIOM3 | Axiom |
Trademark Results [Audioscan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AUDIOSCAN 78503171 3087266 Dead/Cancelled |
Xperex Corporation 2004-10-20 |
 AUDIOSCAN 74035765 not registered Dead/Abandoned |
Essilor International (Compagnie Generale D'Optique) 1990-03-07 |
 AUDIOSCAN 73715485 1606942 Live/Registered |
ETYMONIC DESIGN INCORPORATED 1988-03-02 |
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