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510(k) K072512

MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) by Datex-Ohmeda, Inc. — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2007
Date Received
September 6, 2007
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 Datex-Ohmeda, Inc.

  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K210384 — CARESCAPE R860 (November 4, 2021)
  • K172702 — Tec 820, Tec 850 (January 4, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K151570 — Carestation 620/650/650C (January 21, 2016)
  • K142679 — CARESCAPE R860 (June 12, 2015)
  • K143530 — Aespire View (April 24, 2015)
  • K140575 — ENGSTROM CARESTATION, ENGSTROM PRO (February 3, 2015)

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)