Identifiers
- 510(k) Number
- K022360 FDA 510(k)
- FDA Product Code
- DTA FDA 510(k)
- Models / Variants
- Era 3000 FDA 510(k)Pa-2 Is-1 Adapter FDA 510(k)Ek-4-N Pacemaker Test Cable FDA 510(k)Era 3000 Charger FDA 510(k)Era 3000 Battery (type 2) FDA 510(k)Nk-11 Power Supp. FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3720 FDA 510(k)
- Regulation Number
- 870.3720 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Era 3000 +5 more models by Biotronik, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 6 models — regulatory data on deviCERTS
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 | K022360 | Class II | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K022360 24 fields · synced Jun 18, 2026