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FDA 510(k) Applications Submitted by International Biomedical
FDA 510(k) Number
Submission Date
Device Name
Applicant
K160238
02/01/2016
Airborne Phototherapy Light
INTERNATIONAL BIOMEDICAL
K220742
03/14/2022
NxtGen Infant Transport Incubator
International Biomedical
K140707
03/20/2014
LIFEBORNE INFANT RESUSCITATOR
INTERNATIONAL BIOMEDICAL
K221154
04/21/2022
Infant Heel WarmerTM; Heel Snuggler«
International Biomedical
K221653
06/07/2022
InfaTherm Disposable Infant Warming Mattress
International Biomedical
K182956
10/24/2018
Puffin Lite Infant Resuscitation System
International Biomedical
K173516
11/14/2017
NuBorne Infant Warmer
International Biomedical
K193481
12/17/2019
AeroNOx 2.0 Nitric Oxide Titration & Monitoring System
International Biomedical
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