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Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory …
FDA 510(k)Class II (US FDA 510(k))
510(k) K153193
Identifiers
- 510(k) Number
- K153193 FDA 510(k)
- FDA Product Code
- FRN 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)
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory … by Zyno Medical, LLC — 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 | K153193 | Class II | Active |
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Manufacturer
- Manufacturer
- Zyno Medical, LLC
Sources (1)
- FDA 510(k) K153193 24 fields · synced Jun 18, 2026