The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Adscope 658 Electronic Stethoscope.
| Device ID | K162589 |
| 510k Number | K162589 |
| Device Name: | Adscope 658 Electronic Stethoscope |
| Classification | Stethoscope, Electronic |
| Applicant | AMERICAN DIAGNOSTIC CORP. 55 COMMERCE DR. Hauppauge, NY 11788 |
| Contact | Michael Falco |
| Correspondent | Michael Falco AMERICAN DIAGNOSTIC CORP. 55 COMMERCE DR. Hauppauge, NY 11788 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-16 |
| Decision Date | 2017-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782094201 | K162589 | 000 |
| 00634782584672 | K162589 | 000 |
| 00634782584696 | K162589 | 000 |
| 00634782584702 | K162589 | 000 |
| 00634782584719 | K162589 | 000 |
| 00634782584726 | K162589 | 000 |
| 00634782584733 | K162589 | 000 |
| 00634782584740 | K162589 | 000 |
| 00634782588311 | K162589 | 000 |
| 00634782588328 | K162589 | 000 |
| 00634782094188 | K162589 | 000 |
| 00634782094195 | K162589 | 000 |
| 00634782554576 | K162589 | 000 |