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510(k) K020966

RPI REPLACEMENT HEATING ELEMENTS by Replacement Parts Industries, Inc. — Product Code FMT

K020966 is an FDA 510(k) premarket notification submitted by Replacement Parts Industries, Inc. for the device "RPI REPLACEMENT HEATING ELEMENTS". The FDA issued a decision of Substantially Equivalent on June 13, 2002. The device falls under product code FMT (Warmer, Infant Radiant), a Class II device regulated under 21 CFR 880.5130. Replacement Parts Industries, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2002
Date Received
March 25, 2002
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 Replacement Parts Industries, Inc.

  • K021531 — RPI REPLACEMENT PHOTOTHERAPY LIGHTS (May 31, 2002)
  • K020219 — RPI SKIN OR AIR TEMPERATURE PROBE (April 12, 2002)

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