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510(k) K070291

MEDIX NATAL CARE INTENSIVE CARE INCUBATOR, MODELS-NATAL CARE ST-MX/LX/BX by Medix I.C.S.A. — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2007
Date Received
January 30, 2007
Clearance Type
Traditional
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 Medix I.C.S.A.

  • K103735 — MEDILED MINI (August 15, 2011)
  • K083179 — MEDILED PHOTOTHERAPY LAMP (February 27, 2009)
  • K931529 — INFANT WARMER (March 11, 1994)
  • K931965 — MEDIX PHOTOTHERAPY LAMP (December 9, 1993)
  • K920049 — MEDIX PC-305 NEONATAL INCUBATOR (May 21, 1993)

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)