Becker External Drainage And Monitoring System

Device, Monitoring, Intracranial Pressure

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Becker External Drainage And Monitoring System.

Pre-market Notification Details

Device IDK200456
510k NumberK200456
Device Name:Becker External Drainage And Monitoring System
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant Medtronic, Inc. 125 Cremona Drive Goleta,  CA  93117
ContactNancy Hampton
CorrespondentNancy Hampton
Medtronic, Inc. 125 Cremona Drive Goleta,  CA  93117
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-25
Decision Date2020-03-26

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