Breathe Technologies Life2000™ Ventilation System

Ventilator, Continuous, Facility Use

Breathe Technologies

The following data is part of a premarket notification filed by Breathe Technologies with the FDA for Breathe Technologies Life2000™ Ventilation System.

Pre-market Notification Details

Device IDK170037
510k NumberK170037
Device Name:Breathe Technologies Life2000™ Ventilation System
ClassificationVentilator, Continuous, Facility Use
Applicant Breathe Technologies 175 Technology Drive, Suite 100 Irvine,  CA  92618
ContactSamir Ahmad
CorrespondentCraig Coombs
Coombs Medical Device Consulting, Inc. 1193 Sherman St Alameda,  CA  94501
Product CodeCBK  
Subsequent Product CodeBTI
Subsequent Product CodeNOU
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-04
Decision Date2017-08-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887761978201 K170037 000
00887761978195 K170037 000
00887761978089 K170037 000
00887761974739 K170037 000

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