LIFEBORNE INFANT RESUSCITATOR

Ventilator, Emergency, Powered (resuscitator)

INTERNATIONAL BIOMEDICAL

The following data is part of a premarket notification filed by International Biomedical with the FDA for Lifeborne Infant Resuscitator.

Pre-market Notification Details

Device IDK140707
510k NumberK140707
Device Name:LIFEBORNE INFANT RESUSCITATOR
ClassificationVentilator, Emergency, Powered (resuscitator)
Applicant INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin,  TX  78754
ContactAmy Pieper
CorrespondentAmy Pieper
INTERNATIONAL BIOMEDICAL 8206 CROSS PARK DR. Austin,  TX  78754
Product CodeBTL  
CFR Regulation Number868.5925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-20
Decision Date2014-05-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00868406000051 K140707 000

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