510(k) K020896 ยท DTE Pulse-Generator, Pacemaker, External
OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE
| Applicant | Osypka Medical, Inc., La Jolla CA, US |
| Decision | Substantially Equivalent, Jun 14, 2002 |
| Received | Mar 19, 2002 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K020896
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2010 | Osypka Medical Inc Oscor PACE 203H, Dual-Chamber External Pulse Generator
The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for tem Terminated |
DTE | None listed |
| Sep 21, 2010 | Osypka Medical Inc St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator
The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead sy Terminated |
DTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.