Vivo 45 LS

Continuous, Ventilator, Home Use

Breas Medical AB

The following data is part of a premarket notification filed by Breas Medical Ab with the FDA for Vivo 45 Ls.

Pre-market Notification Details

Device IDK193586
510k NumberK193586
Device Name:Vivo 45 LS
ClassificationContinuous, Ventilator, Home Use
Applicant Breas Medical AB Foretagsvagen 1 Molnlyeke,  SE Se-453 33
ContactAri Sobel
CorrespondentMaureen O'connell
O'Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham,  MA  02180
Product CodeNOU  
Subsequent Product CodeBTT
Subsequent Product CodeCBK
Subsequent Product CodeCCK
Subsequent Product CodeDQA
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2021-01-27

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