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510(k) K941106

Device
MODEL TI500 ISOLETTE INFANT INCUBATOR
Applicant
AIR-SHIELDS, INC.
510(k) number
K941106
Product code
FPL  
Decision
Substantially Equivalent (SESE)
Decision date
1994-06-10
Date received
1994-03-07
Regulation
880.5410
Classification name
Incubator, Neonatal Transport
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
FRANCIS X CASEY
Address
330 Jacksonville Rd. Hatboro PA US 19040 19040

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FPL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220742NxtGen Infant Transport IncubatorInternational Biomedical2022-07-15
K161918SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical Systems2017-03-03
K141565GLOBE-TROTTER GT5400Draeger Medical Systems, Inc.2014-09-10
K123937ATOM TRANSCAPSULE V-707Atom Medical Corporation2013-05-23
K103523185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOXInternational Biomedical, Ltd.2011-05-11
K103525A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOXInternational Biomedical, Ltd.2011-05-11
K103524VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOXInternational Biomedical, Ltd.2011-04-15
K103527AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOXInternational Biomedical, Ltd.2011-04-15
K081399AVIATOR TRANSPORT INCUBATORInternational Biomedical, Ltd.2008-06-06
K061071V-808 ATOM TRANSCAPSULEAtom Medical, Inc.2006-08-29
K062052LMT NOMAG IC 3.0Lmt Lammers Medical Technology GmbH2006-07-31
K033565LMT NOMAG IC 1,5Lmt Lammers Medical Technology GmbH2003-11-21
K031096MODIFICATION TO TRANSPORT INCUBATOR 185International Biomedics, Inc.2003-06-24
K022876MODIFICATION TO INFANT LIFE SUPPORT MODULE-20International Biomedical, Inc.2002-09-11
K001019TI500 GLOBE-TROTTER TRANSPORT SYSTEMHill-Rom Air-Shields2000-04-27

Legacy Summary#

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FDA Review#

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