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510(k) K120937

SUNFLOWER WARNER by Atom Medical Corporation — Product Code FMT

K120937 is an FDA 510(k) premarket notification submitted by Atom Medical Corporation for the device "SUNFLOWER WARNER". The FDA issued a decision of Substantially Equivalent on July 6, 2012. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Atom Medical Corporation has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2012
Date Received
March 28, 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

Other clearances by Atom Medical Corporation

  • K123937 — ATOM TRANSCAPSULE V-707 (May 23, 2013)
  • K111547 — BILI-THERAPY PAD TYPE (April 12, 2012)
  • K103317 — RESUSCITATION UNIT 105 (April 20, 2011)
  • K102542 — RESUSCI FLOW; RESUSCI FLOW 104 (April 6, 2011)
  • K103828 — BILI-THERAPY SPOT TYPE (March 29, 2011)
  • K102227 — INFA WARMER I (January 21, 2011)
  • K102226 — DUAL INCU I (January 4, 2011)
  • K102279 — INCU I (December 29, 2010)
  • K102710 — NEO-SERVO I (December 22, 2010)

Other clearances for product code FMT

  • K243606 — Babyroo TN300 (January 17, 2025)
  • K230278 — Babyroo TN300 (May 30, 2023)
  • 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)

FDA data resources