CereLink ICP Monitor

Device, Monitoring, Intracranial Pressure

Integra LifeSciences Production Corporation

The following data is part of a premarket notification filed by Integra Lifesciences Production Corporation with the FDA for Cerelink Icp Monitor.

Pre-market Notification Details

Device IDK210993
510k NumberK210993
Device Name:CereLink ICP Monitor
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield,  MA  02048
ContactMarybeth Carson
CorrespondentMarybeth Carson
Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield,  MA  02048
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-02
Decision Date2021-04-30

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