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510(k) K060461

V-505 INFA WARMER by Atom Medical, Inc. — Product Code FMT

K060461 is an FDA 510(k) premarket notification submitted by Atom Medical, Inc. for the device "V-505 INFA WARMER". The FDA issued a decision of Substantially Equivalent on April 28, 2006. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Atom Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2006
Date Received
February 22, 2006
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 Atom Medical, Inc.

  • K061856 — V-2200 INFANT INCUBATOR (September 28, 2006)
  • K061071 — V-808 ATOM TRANSCAPSULE (August 29, 2006)
  • K021809 — V-2100G ADVANCED INFANT INCUBATOR (July 18, 2002)
  • K002355 — ATOM INFA WARMER V-505 (October 10, 2000)

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