Osypka Medical, Inc. · Class II · Cleared Jun 14, 2002
| K-number | K020896 |
| Device name | OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MODEL 3085 DUAL-CHAMBER EXTERNAL PULSE GENE |
| Applicant | Osypka Medical, Inc. |
| Product code | DTE |
| Device class | Class II |
| Decision date | Jun 14, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 870.3600 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov