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510(k) K152809

Giraffe Incubator Carestation CS1 by Ohmeda Medical, A Division of Datex-Ohmeda, Inc. — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2015
Date Received
September 28, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Incubator, Neonatal
Device Class
Class II
Regulation Number
880.5400
Review Panel
HO
Submission Type

Other clearances by Ohmeda Medical, A Division of Datex-Ohmeda, Inc.

  • K122267 — GIRAFFE AND PANDA WARMERS (October 2, 2012)
  • K101804 — GIRAFFE AND PANDA WARMERS (July 21, 2010)

Other clearances for product code FMZ

  • K251619 — Babyleo TN500 (February 13, 2026)
  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • K243437 — mOm Essential Incubator (ME1) (August 14, 2025)
  • K213553 — Giraffe Incubator Carestation CS1 (March 2, 2022)
  • K190494 — Infant Incubator (November 25, 2019)
  • K182859 — Babyleo TN500 (February 22, 2019)
  • K182977 — Isolette 8000 Plus (November 21, 2018)
  • K172154 — Isolette 8000 plus (April 19, 2018)
  • K162821 — Babyleo TN500 (June 23, 2017)
  • K152814 — Giraffe OmniBed Carestation CS1 (March 17, 2016)