The following data is part of a premarket notification filed by Oscor Medical Corp. with the FDA for Pacer Sensing Analyzer (psa 100).
| Device ID | K882327 |
| 510k Number | K882327 |
| Device Name: | PACER SENSING ANALYZER (PSA 100) |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Contact | De Graad |
| Correspondent | De Graad OSCOR MEDICAL CORP. 3816 DESOTO BLVD. P.O. BOX 459 Palm Harbor, FL 34683 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-06 |
| Decision Date | 1988-10-06 |