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510(k) K001242

ISOLETTE INFANT INCUBATOR, MODEL C2HS by Hill-Rom Air-Shields — Product Code FMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2000
Date Received
April 18, 2000
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 Hill-Rom Air-Shields

  • K021622 — HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (April 1, 2003)
  • K003335 — RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL (November 17, 2000)
  • K001019 — TI500 GLOBE-TROTTER TRANSPORT SYSTEM (April 27, 2000)
  • K993051 — VERSALET 7700 CARE CENTER, MODEL # 7700 (February 3, 2000)

Other clearances for product code FMZ

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  • 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)