The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Adc 656 Electronic Stethoscope.
| Device ID | K012304 |
| 510k Number | K012304 |
| Device Name: | ADC 656 ELECTRONIC STETHOSCOPE |
| Classification | Stethoscope, Electronic |
| Applicant | AMERICAN DIAGNOSTIC CORP. 55 COMMERCE DR. Hauppauge, NY 11788 |
| Contact | Marc Blitstein |
| Correspondent | Marc Blitstein 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 | 2001-07-20 |
| Decision Date | 2001-11-01 |
| Summary: | summary |