The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Adscope 657bk Electronic Stethoscope, Model 657bk.
| Device ID | K060321 |
| 510k Number | K060321 |
| Device Name: | ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK |
| 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 | 2006-02-09 |
| Decision Date | 2006-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782555238 | K060321 | 000 |