The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Proscopes And Adscopes.
| Device ID | K935944 |
| 510k Number | K935944 |
| Device Name: | PROSCOPES AND ADSCOPES |
| Classification | Stethoscope, Manual |
| Applicant | AMERICAN DIAGNOSTIC CORP. 93 OTIS ST. West Babylon, NY 11704 |
| Contact | Marc Blitstein |
| Correspondent | Marc Blitstein AMERICAN DIAGNOSTIC CORP. 93 OTIS ST. West Babylon, NY 11704 |
| Product Code | LDE |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-03-03 |