Adscope® 658-03
by American Diagnostic Corporation
Adscope® 658-03 is a Class II device made by American Diagnostic Corporation, cleared under FDA 510(k) K162589 on 10 Mar 2017 and listed in FDA GUDID since 11 May 2018 (UDI-DI 00634782094188), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00634782094188 | Date11 May 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162589 | Date10 Mar 2017 | StatusActive |
Official records
- AccessGUDID record 00634782094188
- FDA 510(k) database K162589
Across registries
- FDA 510(k) K162589 decided 10 Mar 2017 Active
- FDA GUDID UDI-DI 00634782094188 listed 11 May 2018 Listed
Timeline
- Cleared FDA 510(k) K162589
- Listed FDA GUDID 00634782094188
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Adscope®
- Generic name
- Electronic acoustic stethoscope
- Model / Ref / Catalog
- 658-03
- Primary DI / UDI-DI
- 00634782094188
- 510(k) Number
- FDA product code
- DQD
- GMDN term
- Electronic acoustic stethoscope
- Device class
- Class II
- Regulation number
- 870.1875
- GUDID distribution status
- In Commercial Distribution
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