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510(k) K230278

Babyroo TN300 by Draeger Medical Systems, Inc. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2023
Date Received
February 1, 2023
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

Other clearances by Draeger Medical Systems, Inc.

  • K243606 — Babyroo TN300 (January 17, 2025)
  • K240312 — Infinity CentralStation Wide (August 1, 2024)
  • K233834 — Infinity Gateway Suite (July 12, 2024)
  • K231477 — Infinity CentralStation Wide, Infinity M300, Infinity M300+ (October 17, 2023)
  • K203579 — Infinity Gateway Suite (June 7, 2022)
  • K203088 — Infinity Acute Care System (IACS) Monitoring System (February 1, 2022)
  • K201764 — Infinity Acute Care System (IACS) Monitoring Solution (December 9, 2021)
  • K200859 — Infinity M300 (August 28, 2020)
  • K182977 — Isolette 8000 Plus (November 21, 2018)
  • K172656 — BiliLux (May 1, 2018)

Other clearances for product code FMT

  • K243606 — Babyroo TN300 (January 17, 2025)
  • K213551 — Giraffe Omnibed Carestation CS1 (March 2, 2022)
  • 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)
  • K121625 — LULLABY TM WARMER (September 14, 2012)