The following data is part of a premarket notification filed by Thomas J. Fogarty, M.d. with the FDA for Oscillometric Pulse Detection Device.
| Device ID | K902453 |
| 510k Number | K902453 |
| Device Name: | OSCILLOMETRIC PULSE DETECTION DEVICE |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | THOMAS J. FOGARTY, M.D. 3270 ALPINE RD. Portola Valley, CA 94028 |
| Contact | Fogarty, Md |
| Correspondent | Fogarty, Md THOMAS J. FOGARTY, M.D. 3270 ALPINE RD. Portola Valley, CA 94028 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-01 |
| Decision Date | 1990-08-23 |