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510(k) K934677

U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE by U.S. Medical Corp. — Product Code FMT

K934677 is an FDA 510(k) premarket notification submitted by U.S. Medical Corp. for the device "U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE". The FDA issued a decision of Substantially Equivalent on July 5, 1994. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. U.S. Medical Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 1994
Date Received
September 28, 1993
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 U.S. Medical Corp.

  • K924440 — U.S. MEDICAL PS-7000 DIALYSIS SCALE (May 26, 1993)
  • K924441 — U.S. MEDICAL PS-6000 WHEELCHAIR SCALE (February 12, 1993)
  • K910582 — U.S. MEDICAL PS-2000 PEDIATRIC SCALE (March 21, 1991)
  • K910583 — U.S. MEDICAL PS-3000 NEONATAL SCALE (March 21, 1991)
  • K910581 — U.S. MEDICAL PS-1000 PEDIATRIC SCALE (March 21, 1991)
  • K896633 — AUTO-CUFF(TM) (February 1, 1990)
  • K801053 — PULSED GALVANIC STIMULATOR, 450-DYNAMAX (June 4, 1980)

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