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Device (4002 +3 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K863883
by Salter Labs
Identifiers
- 510(k) Number
- K863883 FDA 510(k)
- FDA Product Code
- CCK FDA 510(k)
- Models / Variants
- 4002 FDA 510(k)4102 FDA 510(k)4202 Oxy. Delivery FDA 510(k)Co2 Cannula FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1400 FDA 510(k)
- Regulation Number
- 868.1400 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Device (4002 +3 more) by Salter Labs — Class II — FDA_510K — listed in FDA 510(k) — 4 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 | K863883 | Class II | Active |
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Manufacturer
- Manufacturer
- Salter Labs
Sources (1)
- FDA 510(k) K863883 24 fields · synced Jun 19, 2026