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Device, Monitoring, Intracranial Pressure

FDA product code GWM · 103 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1620
Review panel
NE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1978-01-03 – 2026-04-10
GWM 2025-08-29

NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOL

Applicant Raumedic AG

K number K250285

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