Puffin Lite Infant Resuscitation System

Ventilator, Emergency, Powered (resuscitator)

International Biomedical

The following data is part of a premarket notification filed by International Biomedical with the FDA for Puffin Lite Infant Resuscitation System.

Pre-market Notification Details

Device IDK182956
510k NumberK182956
Device Name:Puffin Lite Infant Resuscitation System
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant International Biomedical 8206 Cross Park Drive Austin,  TX  78754
ContactAmy Pieper
CorrespondentAmy Pieper
International Biomedical 8206 Cross Park Drive Austin,  TX  78754
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-24
Decision Date2019-01-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865648000344 K182956 000

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