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510(k) K003335

RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER by Hill-Rom Air-Shields — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2000
Date Received
October 25, 2000
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 Hill-Rom Air-Shields

  • K021622 — HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (April 1, 2003)
  • K001242 — ISOLETTE INFANT INCUBATOR, MODEL C2HS (July 13, 2000)
  • K001019 — TI500 GLOBE-TROTTER TRANSPORT SYSTEM (April 27, 2000)
  • K993051 — VERSALET 7700 CARE CENTER, MODEL # 7700 (February 3, 2000)

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  • 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)