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FDA 510(k)

Pressio 2 ICP Monitoring System

K-Number: K162108 · 2017-04-17

ApplicantSophysa SA
Decision Date2017-04-17
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Pressio 2 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 2017-04-17 under 510(k) number K162108. 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 2 ICP Monitoring System?

Pressio 2 ICP Monitoring System is a medical device that received FDA 510(k) clearance on 2017-04-17. The listed applicant is Sophysa SA. The 510(k) number is K162108.

When did Pressio 2 ICP Monitoring System receive FDA 510(k) clearance?

Pressio 2 ICP Monitoring System received FDA 510(k) clearance on 2017-04-17, under 510(k) number K162108.

Who is the listed applicant for Pressio 2 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 2 ICP Monitoring System?

The FDA product code for Pressio 2 ICP Monitoring System is GWM.

Other records listing Sophysa SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemK250636Sophy Mini Monopressure Valve (SM1)K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersK222422Polaris Valve Electronic Reading Instrument

Related Devices (Code: GWM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaK250285NEUROVENT-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 AGK240821B4C 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 CorporationK201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

Official Source

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