Skip to content

Temperature PROBE-TP650

by Contour Medical Technology, Inc. 510(k)

Active United States

510(k) K952807

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952807 Date4 Apr 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FMT
Device Class
Class II
Regulation
21 CFR Part 880.5130
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a temperature probe, specifically identified as the TEMPERATURE PROBE-TP650. It is classified under product code FMT and regulation number 880.5130, with a device name of Warmer, Infant Radiant in the FDA database.

It received FDA 510(k) clearance under K952807 on April 4, 1996, as substantially equivalent to a predicate device. The probe is manufactured by Contour Medical Technology, Inc., and is intended for use in general hospital settings.

Other devices from Contour Medical Technology, Inc.

See all devices from Contour Medical Technology, Inc. →