ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.

Ventilator, Non-continuous (respirator)

BREAS MEDICAL AB

The following data is part of a premarket notification filed by Breas Medical Ab with the FDA for Isleep By Breas, Models Isleep 10, Isleep 20..

Pre-market Notification Details

Device IDK060657
510k NumberK060657
Device Name:ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
ClassificationVentilator, Non-continuous (respirator)
Applicant BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke,  SE 435 33
ContactKarl-johan Holm
CorrespondentKarl-johan Holm
BREAS MEDICAL AB FORETAGSVAGEN 1 Molnlycke,  SE 435 33
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-13
Decision Date2006-08-18
Summary:summary

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