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HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY - 6 Therapy, Model 13086
FDA 510(k)Class II (US FDA 510(k))
510(k) K060806
Identifiers
- 510(k) Number
- K060806 FDA 510(k)
- FDA Product Code
- FRN FDA 510(k)
- Models / Variants
- 6 Therapy, Model 13086 FDA 510(k)Pain Management, Model 13088 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)
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY - 6 Therapy, Model 13086 by Hospira, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 models
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 | K060806 | Class II | Active |
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Manufacturer
- Manufacturer
- Hospira, Inc.
Sources (1)
- FDA 510(k) K060806 24 fields · synced Jun 19, 2026