Exacta External Drainage And Monitoring System, Exacta Pole With Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level

Device, Monitoring, Intracranial Pressure

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Exacta External Drainage And Monitoring System, Exacta Pole With Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level.

Pre-market Notification Details

Device IDK201118
510k NumberK201118
Device Name:Exacta External Drainage And Monitoring System, Exacta Pole With Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant Medtronic, Inc. 5290 California Ave Irvine,  CA  92617
ContactJen Correa
CorrespondentJen Correa
Medtronic, Inc. 5290 California Ave Irvine,  CA  92617
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-27
Decision Date2020-05-26

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