Adscope 658 Electronic Stethoscope
510(k) K162589
Adscope 658 Electronic Stethoscope is a Class II device made by American Diagnostic Corp., cleared under FDA 510(k) K162589 on 10 Mar 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162589 | Date10 Mar 2017 | StatusActive |
Official records
- FDA 510(k) database K162589
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQD
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1875
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K162589
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Adscope® 658-03 | 658-03 / 658-03 | 00634782094188 | On the market | |
| Adscope® 658BAT | 658BAT / 658BAT | 00634782094195 | On the market | |
| Adscope® 658BD | 658BD / 658BD | 00634782083298 | On the market | |
| Adscope® 658BK | 658BK / 658BK | 00634782054793 | On the market | |
| Adscope® 658DG | 658DG / 658DG | 00634782083304 | On the market | |
| Adscope® 658MCA | 658MCA / 658MCA | 00634782083311 | On the market | |
| Adscope® 658MCB | 658MCB / 658MCB | 00634782083328 | On the market | |
| Adscope® 658MG | 658MG / 658MG | 00634782083335 | On the market | |
| Adscope® 658MRS | 658MRS / 658MRS | 00634782083342 | On the market | |
| Adscope® 658N | 658N / 658N | 00634782083359 | On the market | |
| Adscope® 658OH | 658OH / 658OH | 00634782086886 | On the market | |
| Adscope® 658PBCA | 658PBCA / 658PBCA | 00634782086893 | On the market | |
| Adscope® 658USB | 658-USB / 658USB | 00634782094201 | On the market |
Similar devices
Other devices filed under FDA product code DQD (Stethoscope, Electronic).
- ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. by Chip Ideas Electronics S.L.
- Tyto Stethoscope (G3) by TYTO CARE LTD
- STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX by Andromed, Inc.
- AccurSound Electronic Stethoscope AS-101 by Heroic Faith International, Ltd.
- PROTRON TECHNOLOGIES, LLC STETHOTRON by Protron Technologies, LLC
- RNK TELEPHONIC STETHOSCOPE, MODEL TR-1 by Rnk Products, Inc.
- CliniCloud Stethoscope by Stethocloud Pty.Ltd (Clinicloud)
- PROCEDURE PACKS SOLUTION ADMINISTRATION SETS by Procedure Packs, Inc.
- ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200 by Erecords Enterprises
- ELECTRONIC-AMPLIFIED STETHOSCOPE by Hsues' Brothers Medical, Inc.