FDA 510(k)

RAUMEDIC ICP MONITORING SYSTEM

K-Number: K112017 · 2011-10-11

Decision Date2011-10-11

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 2011-10-11 under 510(k) number K112017. 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 2011-10-11. The listed applicant is Raumedic AG. The 510(k) number is K112017.

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

RAUMEDIC ICP MONITORING SYSTEM received FDA 510(k) clearance on 2011-10-11, under 510(k) number K112017.

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 K103206RAUMEDIC- 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.