FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
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
K Number: K250285
·
Decision Aug 29, 2025
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
104
Applicant Total
6
Review Days
210
Basic Information
- Device Name
- 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
- K Number
- K250285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1620
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Raumedic AG
- Date Received
- January 31, 2025
- Decision Date
- August 29, 2025
- Product Code
- GWM
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | FDA class 2 | Neurology |
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Other Clearances by Raumedic AG
| K Number | Device Name | ||
|---|---|---|---|
| K171666 | MPR2 logO DATALOGGER | Jul 6, 2017 | Substantially Equivalent |
| K130529 | RAUMEDIC-PTO-MONITORING-SYSTEM | Oct 25, 2013 | Substantially Equivalent |
| K120252 | RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM | Apr 11, 2012 | Substantially Equivalent |
| K112017 | RAUMEDIC ICP MONITORING SYSTEM | Oct 11, 2011 | Substantially Equivalent |
| K103206 | RAUMEDIC- ICP-MONITORING SYSTEM | Mar 4, 2011 | Substantially Equivalent |