FDA 510(k)

RAUMEDIC- ICP-MONITORING SYSTEM

K-Number: K103206 · 2011-03-04

Decision Date2011-03-04

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

RAUMEDIC- ICP-MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Raumedic AG. It received FDA 510(k) clearance on 2011-03-04 under 510(k) number K103206. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAUMEDIC- ICP-MONITORING SYSTEM?

RAUMEDIC- ICP-MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-04. The listed applicant is Raumedic AG. The 510(k) number is K103206.

When did RAUMEDIC- ICP-MONITORING SYSTEM receive FDA 510(k) clearance?

RAUMEDIC- ICP-MONITORING SYSTEM received FDA 510(k) clearance on 2011-03-04, under 510(k) number K103206.

Who is the listed applicant for RAUMEDIC- ICP-MONITORING SYSTEM?

The FDA 510(k) record lists Raumedic AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAUMEDIC- ICP-MONITORING SYSTEM?

The FDA product code for RAUMEDIC- ICP-MONITORING SYSTEM is GWM.

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Other records listing Raumedic AG as applicant

K250285NEUROVENT-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 K171666MPR2 logO DATALOGGER K130529RAUMEDIC-PTO-MONITORING-SYSTEM K120252RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM K112017RAUMEDIC ICP MONITORING SYSTEM

Related Devices (Code: GWM)

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa K250285NEUROVENT-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); BOLRaumedic AG K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.