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FDA 510(k)

NEUROSENSOR

K-Number: K013930 · 2002-02-20

ApplicantNovus Monitoring, Ltd.
Decision Date2002-02-20
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROSENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Novus Monitoring, Ltd.. It received FDA 510(k) clearance on 2002-02-20 under 510(k) number K013930. 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 NEUROSENSOR?

NEUROSENSOR is a medical device that received FDA 510(k) clearance on 2002-02-20. The listed applicant is Novus Monitoring, Ltd.. The 510(k) number is K013930.

When did NEUROSENSOR receive FDA 510(k) clearance?

NEUROSENSOR received FDA 510(k) clearance on 2002-02-20, under 510(k) number K013930.

Who is the listed applicant for NEUROSENSOR?

The FDA 510(k) record lists Novus Monitoring, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROSENSOR?

The FDA product code for NEUROSENSOR is GWM.

Related Clinical Trials

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.

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Other records listing Novus Monitoring, Ltd. 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.

K042728CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM

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

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