← Back to catalogue
Ivf 20, Ivf 50, Ivf 500, Ivf 500 Antibiotic Free (2420 +3 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K991348
Identifiers
- 510(k) Number
- K991348 FDA 510(k)
- FDA Product Code
- MQL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.6180 FDA 510(k)
- Regulation Number
- 884.6180 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ivf 20, Ivf 50, Ivf 500, Ivf 500 Antibiotic Free (2420 +3 more) by Vitrolife Sweden AB — Class II — FDA_510K — listed in FDA 510(k) — 4 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 | K991348 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitrolife Sweden AB
Sources (1)
- FDA 510(k) K991348 24 fields · synced Jun 18, 2026