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Oxygen Analyzer (Aii 20000a +2 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K053407
Identifiers
- 510(k) Number
- K053407 FDA 510(k)
- FDA Product Code
- CCL FDA 510(k)
- Models / Variants
- Aii 20000a FDA 510(k)Aii 2000hc FDA 510(k)Aii 2000m FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.1720 FDA 510(k)
- Regulation Number
- 868.1720 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Oxygen Analyzer (Aii 20000a +2 more) by Analytical Industries, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K053407 | Class II | Active |
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Manufacturer
- Manufacturer
- Analytical Industries, Inc.
Sources (1)
- FDA 510(k) K053407 24 fields · synced Jun 19, 2026