The following data is part of a premarket notification filed by Osypka Medical, Inc. with the FDA for Oscor Pace 203/pace 203h Dual-chamber Temporary Pacemaker, St. Jude Medical, Model 3085 Dual-chamber External Pulse Gene.
| Device ID | K020896 |
| 510k Number | K020896 |
| Device Name: | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | OSYPKA MEDICAL, INC. 7463 DRAPER AVE. La Jolla, CA 92037 |
| Contact | Markus J Osypka |
| Correspondent | Markus J Osypka OSYPKA MEDICAL, INC. 7463 DRAPER AVE. La Jolla, CA 92037 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-19 |
| Decision Date | 2002-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885672005467 | K020896 | 000 |
| 04260451441029 | K020896 | 000 |
| 00836559008866 | K020896 | 000 |
| 04260451441067 | K020896 | 000 |