Home / 510(k) Clearances / K942905

510(k) K942905

DISPOSABLE TEMPERATURE PROBE COVER by Arbo Medical, Inc. — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1995
Date Received
June 21, 1994
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 Arbo Medical, Inc.

  • K940323 — ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & (April 12, 1995)
  • K935437 — ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES (April 6, 1995)
  • K940302 — ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & L (November 30, 1994)
  • K940322 — ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE (November 28, 1994)
  • K935246 — ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES (November 16, 1994)
  • K935429 — ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES (November 1, 1994)
  • K935281 — ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES (September 6, 1994)
  • K905545 — ULTRASOUND TRANSMISSION GEL (March 29, 1991)
  • K902788 — CLEM TM (September 12, 1990)
  • K901816 — PRESSURE TUBING AND ACCESSORIES (July 12, 1990)

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)