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Oscor Pace 203/Pace 203h Dual-Chamber Temporary Pacemaker, St. Jude Medical, Mo…
FDA 510(k)Class II (US FDA 510(k))
510(k) K020896
Identifiers
- 510(k) Number
- K020896 FDA 510(k)
- FDA Product Code
- DTE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3600 FDA 510(k)
- Regulation Number
- 870.3600 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Oscor Pace 203/Pace 203h Dual-Chamber Temporary Pacemaker, St. Jude Medical, Mo… by Osypka Medical, Inc. — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020896 | Class II | Active |
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Manufacturer
- Manufacturer
- Osypka Medical, Inc.
Sources (1)
- FDA 510(k) K020896 24 fields · synced Jun 18, 2026