PARENCHYMAL BOLT PRESSURE MONITORING KIT

Device, Monitoring, Intracranial Pressure

CAMINO NEUROCARE, INC.

The following data is part of a premarket notification filed by Camino Neurocare, Inc. with the FDA for Parenchymal Bolt Pressure Monitoring Kit.

Pre-market Notification Details

Device IDK981846
510k NumberK981846
Device Name:PARENCHYMAL BOLT PRESSURE MONITORING KIT
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant CAMINO NEUROCARE, INC. 5955 PACIFIC CENTER BLVD. San Diego,  CA  92121
ContactJody J Fleming
CorrespondentJody J Fleming
CAMINO NEUROCARE, INC. 5955 PACIFIC CENTER BLVD. San Diego,  CA  92121
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-26
Decision Date1998-08-18

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