FDA 510(k)

PRESSIO ICP MONITORING SYSTEM

K-Number: K062584 · 2007-07-05

Decision Date2007-07-05

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PRESSIO ICP MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sophysa SA. It received FDA 510(k) clearance on 2007-07-05 under 510(k) number K062584. 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 PRESSIO ICP MONITORING SYSTEM?

PRESSIO ICP MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-07-05. The listed applicant is Sophysa SA. The 510(k) number is K062584.

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

PRESSIO ICP MONITORING SYSTEM received FDA 510(k) clearance on 2007-07-05, under 510(k) number K062584.

Who is the listed applicant for PRESSIO ICP MONITORING SYSTEM?

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

What is the FDA product code for PRESSIO ICP MONITORING SYSTEM?

The FDA product code for PRESSIO ICP MONITORING SYSTEM is GWM.

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Other records listing Sophysa SA as applicant

K162108Pressio 2 ICP Monitoring System K091328SIPHONX GRAVITATIONAL ANTISIPHON DEVICE K090342POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 K042481POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 K031097POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB K013488SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8

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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

View on FDA Database →

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