The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Aneroid And Mercurial Sphygmomanometers.
| Device ID | K962655 |
| 510k Number | K962655 |
| Device Name: | ANEROID AND MERCURIAL SPHYGMOMANOMETERS |
| Classification | Blood Pressure Cuff |
| 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 | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-08 |
| Decision Date | 1997-01-27 |