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510(k) K101804

GIRAFFE AND PANDA WARMERS by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2010
Date Received
June 28, 2010
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, A Division of Datex-Ohmeda, Inc.

  • K152809 — Giraffe Incubator Carestation CS1 (December 31, 2015)
  • K122267 — GIRAFFE AND PANDA WARMERS (October 2, 2012)

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)