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510(k) K070377

GIRAFFE AND PANDA WARMER by Ohmeda Medical — Product Code FMT

K070377 is an FDA 510(k) premarket notification submitted by Ohmeda Medical for the device "GIRAFFE AND PANDA WARMER". The FDA issued a decision of Substantially Equivalent on July 11, 2007. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Ohmeda Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2007
Date Received
February 8, 2007
Clearance Type
Traditional
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)
  • K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER (April 16, 2009)
  • K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POW (August 27, 2007)
  • K070247 — GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM (April 20, 2007)
  • K070210 — GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM (April 20, 2007)
  • K040068 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM (April 16, 2004)
  • K020543 — OHMEDA MEDICAL GIRAFFE OMNIBED (May 9, 2002)
  • K020547 — OHMEDA MEDICAL GIRAFFE INCUBATOR (May 9, 2002)

Other clearances for product code FMT

  • K243606 — Babyroo TN300 (January 17, 2025)
  • K230278 — Babyroo TN300 (May 30, 2023)
  • 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)

FDA data resources