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Ambu® aScope Gastro Large - Ambu® aBox™ 2
FDA 510(k)Class II (US FDA 510(k))
510(k) K232919
by Ambu A/S
Identifiers
- 510(k) Number
- K232919 FDA 510(k)
- FDA Product Code
- FDS FDA 510(k)
- Models / Variants
- Ambu® aScope™ Gastro Large FDA 510(k)Ambu® aBox™ 2 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ambu® aScope Gastro Large - Ambu® aBox™ 2 by Ambu A/S — Class II — FDA_510K — listed in FDA 510(k) — 2 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 | K232919 | Class II | Active |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA 510(k) K232919 24 fields · synced Jun 19, 2026