RESUSCI FLOW; RESUSCI FLOW 104

Ventilator, Emergency, Powered (resuscitator)

ATOM MEDICAL CORPORATION

The following data is part of a premarket notification filed by Atom Medical Corporation with the FDA for Resusci Flow; Resusci Flow 104.

Pre-market Notification Details

Device IDK102542
510k NumberK102542
Device Name:RESUSCI FLOW; RESUSCI FLOW 104
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant ATOM MEDICAL CORPORATION 24301 WOODSTAGE DRIVE Bonita Springs,  FL  34134
ContactPaul Dryden
CorrespondentPaul Dryden
ATOM MEDICAL CORPORATION 24301 WOODSTAGE DRIVE Bonita Springs,  FL  34134
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-03
Decision Date2011-04-06
Summary:summary

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