FDA 510(k) Applications for Medical Device Product Code: FPL (Incubator, Neonatal Transport)

FDA 510(k) Applications for Medical Device Product Code "FPL"
(Incubator, Neonatal Transport)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K161918	ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS	SREE MRI Transport Incubator	03/03/2017
K123937	ATOM MEDICAL CORPORATION	ATOM TRANSCAPSULE V-707	05/23/2013
K061071	ATOM MEDICAL INC	V-808 ATOM TRANSCAPSULE	08/29/2006
K141565	Draeger Medical Systems, Inc.	GLOBE-TROTTER GT5400	09/10/2014
K001019	HILL-ROM AIR-SHIELDS	TI500 GLOBE-TROTTER TRANSPORT SYSTEM	04/27/2000
K220742	International Biomedical	NxtGen Infant Transport Incubator	07/15/2022
K022876	INTERNATIONAL BIOMEDICAL, INC.	MODIFICATION TO INFANT LIFE SUPPORT MODULE-20	09/11/2002
K103523	INTERNATIONAL BIOMEDICAL, LTD.	185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX	05/11/2011
K103525	INTERNATIONAL BIOMEDICAL, LTD.	A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX	05/11/2011
K081399	INTERNATIONAL BIOMEDICAL, LTD.	AVIATOR TRANSPORT INCUBATOR	06/06/2008
K103527	INTERNATIONAL BIOMEDICAL, LTD.	AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX	04/15/2011
K103524	INTERNATIONAL BIOMEDICAL, LTD.	VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX	04/15/2011
K031096	INTERNATIONAL BIOMEDICS, INC.	MODIFICATION TO TRANSPORT INCUBATOR 185	06/24/2003
K033565	LMT LAMMERS MEDICAL TECHNOLOGY GMBH	LMT NOMAG IC 1,5	11/21/2003
K062052	LMT LAMMERS MEDICAL TECHNOLOGY GMBH	LMT NOMAG IC 3.0	07/31/2006