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ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Int…
FDA 510(k)Class II (US FDA 510(k))
510(k) K162165
Identifiers
- 510(k) Number
- K162165 FDA 510(k)
- FDA Product Code
- MEA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Int… by Summit Medical Products, 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 | K162165 | Class II | Active |
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Manufacturer
- Manufacturer
- Summit Medical Products, Inc.
Sources (1)
- FDA 510(k) K162165 24 fields · synced Jun 18, 2026