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FMT — Warmer, Infant Radiant Class II

FDA Device Classification

Classification Details

Product Code
FMT
Device Class
Class II
Regulation Number
880.5130
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243606draeger medical systemsBabyroo TN300January 17, 2025
K230278draeger medical systemsBabyroo TN300May 30, 2023
K213551datex ohmedaGiraffe Omnibed Carestation CS1March 2, 2022
K201628ge healthcarePanda iRes Warmer, Giraffe WarmerFebruary 12, 2021
K200319deroyal industriesHYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin SuApril 2, 2020
K191425deroyal industriesHydro-Temp Neonatal Skin Temperature Probe CoverJanuary 21, 2020
K173516international biomedicalNuBorne Infant WarmerAugust 17, 2018
K123309ohmeda medicalGIRAFFE AND PANDA WARMERSFebruary 5, 2013
K120642draeger medical systemsRESUSCITAIRE WITH AUTOBREATHNovember 2, 2012
K122267ohmeda medical, a division of datex-ohmedaGIRAFFE AND PANDA WARMERSOctober 2, 2012
K121625wipro ge healthcare privateLULLABY TM WARMERSeptember 14, 2012
K120937atom medical corporationSUNFLOWER WARNERJuly 6, 2012
K102227atom medical corporationINFA WARMER IJanuary 21, 2011
K101804ohmeda medical, a division of datex-ohmedaGIRAFFE AND PANDA WARMERSJuly 21, 2010
K090697ohmeda medicalMODIFICATION TO: GIRAFFE AND PANDA WARMERApril 16, 2009
K072157ohmeda medicalMODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWAugust 27, 2007
K070377ohmeda medicalGIRAFFE AND PANDA WARMERJuly 11, 2007
K060461atom medicalV-505 INFA WARMERApril 28, 2006
K033040international hospital supplyPHOENIX INFANT RADIANT WARMER, MODEL 100NWSDecember 17, 2003
K020966replacement parts industriesRPI REPLACEMENT HEATING ELEMENTSJune 13, 2002