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Neurovent-P (092946-003) +16 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K250285
by Raumedic Ag
Identifiers
- 510(k) Number
- K250285 FDA 510(k)
- FDA Product Code
- GWM FDA 510(k)
- Models / Variants
- Neurovent-P (092946-003) FDA 510(k)Neurovent (092956-003) FDA 510(k)Neurovent-Ifd-R (095317-003) FDA 510(k)Neurovent-Ifd-S (091678-003) FDA 510(k)Neurovent-P-Temp (094268-003) FDA 510(k)Neurovent-Temp (094278-003) FDA 510(k)Neurovent-Temp-Ifd-R (095327-003) FDA 510(k)Neurovent-Temp-Ifd-S (094288-003) FDA 510(k)Neurovent-Pto (095008-003) FDA 510(k)Neurovent-Pto 2l (095108-003) FDA 510(k)Neurovent-Px (091580-003) FDA 510(k)Bolt-Drill Kit Ch5 (091888-003) FDA 510(k)Bolt-Drill Kit Ch9 (091898-003) FDA 510(k)Bolt-Drill Kit Pto (092380-003) FDA 510(k)Bolt-Drill Kit Vp 16 (092969-003) FDA 510(k)Bolt Kit Ch5 (091868-003) FDA 510(k)Bol FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1620 FDA 510(k)
- Regulation Number
- 882.1620 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Neurovent-P (092946-003) +16 more models by Raumedic Ag — Class II — FDA_510K — listed in FDA 510(k) — 17 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 | K250285 | Class II | Active |
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Manufacturer
- Manufacturer
- Raumedic Ag
Sources (1)
- FDA 510(k) K250285 24 fields · synced Jun 18, 2026