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FDA 510(k)

CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM

K-Number: K042728 · 2004-10-22

ApplicantNovus Monitoring, Ltd.
Decision Date2004-10-22
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM 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 2004-10-22 under 510(k) number K042728. 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 CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM?

CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-22. The listed applicant is Novus Monitoring, Ltd.. The 510(k) number is K042728.

When did CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM receive FDA 510(k) clearance?

CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM received FDA 510(k) clearance on 2004-10-22, under 510(k) number K042728.

Who is the listed applicant for CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM?

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 CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM?

The FDA product code for CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM 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.

K013930NEUROSENSOR

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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