The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for External Demand Pacemaker.
| Device ID | K923621 |
| 510k Number | K923621 |
| Device Name: | EXTERNAL DEMAND PACEMAKER |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Contact | Den Nieuwenho |
| Correspondent | Den Nieuwenho OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1993-05-19 |