TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP

Device, Monitoring, Intracranial Pressure

MEDEX, INC.

The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Transtar Intracranial Pressure Transducer, Model Mx950icp.

Pre-market Notification Details

Device IDK020780
510k NumberK020780
Device Name:TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant MEDEX, INC. 6250 SHIER RINGS RD. Dublin,  OH  43016
ContactBarbara Law
CorrespondentBarbara Law
MEDEX, INC. 6250 SHIER RINGS RD. Dublin,  OH  43016
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-11
Decision Date2002-05-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.