FDA.reportPublic FDA data

510(k) K200319

Device
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor With Interface Cable
Applicant
DeRoyal Industries, Inc.
510(k) number
K200319
Product code
FMT  
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-02
Date received
2020-02-07
Regulation
880.5130
Classification name
Warmer, Infant Radiant
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sarah Bennett
Address
200 Debusk Ln. Powell TN US 37849 37849

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FMT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243606Babyroo TN300Draeger Medical Systems, Inc.2025-01-17
K230278Babyroo TN300Draeger Medical Systems, Inc.2023-05-30
K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.2022-03-02
K201628Panda iRes Warmer, Giraffe WarmerGE Healthcare2021-02-12
K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc.2020-01-21
K173516NuBorne Infant WarmerInternational Biomedical2018-08-17
K123309GIRAFFE AND PANDA WARMERSOhmeda Medical2013-02-05
K120642RESUSCITAIRE WITH AUTOBREATHDraeger Medical Systems, Inc.2012-11-02
K122267GIRAFFE AND PANDA WARMERSOhmeda Medical, A Division of Datex-Ohmeda, Inc.2012-10-02
K121625LULLABY TM WARMERWipro GE Healthcare Private, Ltd.2012-09-14
K120937SUNFLOWER WARNERAtom Medical Corporation2012-07-06
K102227INFA WARMER IAtom Medical Corporation2011-01-21
K101804GIRAFFE AND PANDA WARMERSOhmeda Medical, A Division of Datex-Ohmeda, Inc.2010-07-21
K090697MODIFICATION TO: GIRAFFE AND PANDA WARMEROhmeda Medical2009-04-16
K072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)Ohmeda Medical2007-08-27

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases