Temperature PROBE-TP350

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K952803 ↗

FDA Product Code

FMT

Device Class

Class II

Regulation

21 CFR Part 880.5130

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Temperature Probe-TP450

  Class II

  FDA 510(k) K952804 Active Cleared 4 Apr 1996

• Quantum Edge Pediatric Defirbrillation Electrodes

  Class III

  FDA 510(k) K970391 Active Cleared 6 Mar 1997

• Temperature Probe-TP550

  Class II

  FDA 510(k) K952805 Active Cleared 4 Apr 1996

• Noah Monitoring Electrode System

  Class II

  FDA 510(k) K970125 Active Cleared 4 Mar 1997

• Temperature PROBE-TP650

  Class II

  FDA 510(k) K952807 Active Cleared 4 Apr 1996

• Disposable Hydrogel Defibrillation Electrode/Pad

  Class III

  FDA 510(k) K960329 Active Cleared 2 Jul 1996

See all devices from Contour Medical Technology, Inc. →

• What is the Temperature Probe-TP350 used for?

  The Temperature Probe-TP350 is designed for temperature monitoring and control in general hospital settings. It includes a temperature monitoring sensor, heat output control mechanism, and alarm system to alert operators of temperature conditions exceeding set parameters, manual mode time limits, or device component failures.

• Is the Temperature Probe-TP350 single-use or reusable?

  The device data does not specify whether the Temperature Probe-TP350 is single-use or reusable. The description only indicates it is manufactured by Contour Medical Technology, Inc. and includes features for infant temperature monitoring and manual mode operation with appropriate safety alarms.

• What are the regulatory approvals for the Temperature Probe-TP350?

  The Temperature Probe-TP350 is authorized under FDA 510K clearance K952803. It is classified under product code FMT and is intended for use in general hospital settings. The device has been determined to be substantially equivalent to predicate devices.

• What sizes or models of the Temperature Probe-TP350 are available?

  The device data does not specify different sizes or models of the Temperature Probe-TP350. It only mentions the device name as TEMPERATURE PROBE-TP350 with model number TP350, manufactured by Contour Medical Technology, Inc.