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510(k) K120642

RESUSCITAIRE WITH AUTOBREATH by Draeger Medical Systems, Inc. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2012
Date Received
March 2, 2012
Clearance Type
Traditional
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

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Other clearances for product code FMT

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  • K213551 — Giraffe Omnibed Carestation CS1 (March 2, 2022)
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  • 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)
  • K122267 — GIRAFFE AND PANDA WARMERS (October 2, 2012)
  • K121625 — LULLABY TM WARMER (September 14, 2012)