FDA 510(k)

VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD

K-Number: K982702 · 1998-09-10

Decision Date1998-09-10

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD is the device name listed in this FDA 510(k) record. The listed applicant is Camino Neurocare, Inc.. It received FDA 510(k) clearance on 1998-09-10 under 510(k) number K982702. 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 VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD?

VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD is a medical device that received FDA 510(k) clearance on 1998-09-10. The listed applicant is Camino Neurocare, Inc.. The 510(k) number is K982702.

When did VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD receive FDA 510(k) clearance?

VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD received FDA 510(k) clearance on 1998-09-10, under 510(k) number K982702.

Who is the listed applicant for VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD?

The FDA 510(k) record lists Camino Neurocare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD?

The FDA product code for VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD is GWM.

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Other records listing Camino Neurocare, Inc. as applicant

K981846PARENCHYMAL BOLT PRESSURE MONITORING KIT K962928COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)

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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