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510(k) K090697

MODIFICATION TO: GIRAFFE AND PANDA WARMER by Ohmeda Medical — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2009
Date Received
March 17, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type

Other clearances by Ohmeda Medical

  • K123309 — GIRAFFE AND PANDA WARMERS (February 5, 2013)
  • K101778 — GIRAFFE INCUBATOR (July 21, 2010)
  • K101788 — GIRAFFE OMNIBED (July 21, 2010)
  • K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POW (August 27, 2007)
  • K070377 — GIRAFFE AND PANDA WARMER (July 11, 2007)
  • K070210 — GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM (April 20, 2007)
  • K070247 — GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM (April 20, 2007)
  • K040068 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM (April 16, 2004)
  • K020547 — OHMEDA MEDICAL GIRAFFE INCUBATOR (May 9, 2002)
  • K020543 — OHMEDA MEDICAL GIRAFFE OMNIBED (May 9, 2002)

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  • K213551 — Giraffe Omnibed Carestation CS1 (March 2, 2022)
  • K201628 — Panda iRes Warmer, Giraffe Warmer (February 12, 2021)
  • K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Su (April 2, 2020)
  • K191425 — Hydro-Temp Neonatal Skin Temperature Probe Cover (January 21, 2020)
  • K173516 — NuBorne Infant Warmer (August 17, 2018)
  • K123309 — GIRAFFE AND PANDA WARMERS (February 5, 2013)
  • K120642 — RESUSCITAIRE WITH AUTOBREATH (November 2, 2012)
  • K122267 — GIRAFFE AND PANDA WARMERS (October 2, 2012)