Medical Device Manufacturer · DE , Helmbrechts

Raumedic AG - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2011

Recent clearances: NEUROVENT-P (092946-003), MPR2 logO DATALOGGER, RAUMEDIC-PTO-MONITORING-SYSTEM

6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Raumedic AG Neurology ✕

6 devices
1-6 of 6
Cleared Aug 29, 2025
NEUROVENT-P (092946-003)
K250285 · GWM
Neurology · 210d
Cleared Jul 06, 2017
MPR2 logO DATALOGGER
K171666 · GWM
Neurology · 31d
Cleared Oct 25, 2013
RAUMEDIC-PTO-MONITORING-SYSTEM
K130529 · GWM
Neurology · 238d
Cleared Apr 11, 2012
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
K120252 · GWM
Neurology · 75d
Cleared Oct 11, 2011
RAUMEDIC ICP MONITORING SYSTEM
K112017 · GWM
Neurology · 89d
Cleared Mar 04, 2011
RAUMEDIC- ICP-MONITORING SYSTEM
K103206 · GWM
Neurology · 123d
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