Model 1000 Electronic Clinical Thermometer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K885187 ↗

FDA Product Code

FLL

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Mon-A-Therm's Skin Temperature Sensor

  Class II

  FDA 510(k) K875234 Active Cleared 19 Jan 1988

• Modified Airway Temperature Sensor

  Class II

  FDA 510(k) K874520 Active Cleared 6 Jan 1988

• Modified Foley Catheter/Temperature Sensor

  Class II

  FDA 510(k) K874525 Active Cleared 6 Jan 1988

• Modified Esophageal Stethoscope/Temperature Sensor

  Class I

  FDA 510(k) K874519 Active Cleared 29 Jan 1988

• Temperature Trend Indicator (TTI)

  Class II

  FDA 510(k) K820426 Active Cleared 8 Mar 1982

• Modified Tympanic & Esophageal/Rectal Temp. Sensor

  Class II

  FDA 510(k) K874523 Active Cleared 6 Jan 1988

See all devices from Mon-A-Therm, Inc. →

• What is the Model 1000 Electronic Clinical Thermometer used for?

  The Model 1000 Electronic Clinical Thermometer is used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. It is intended for general hospital use as determined by its FDA 510(k) clearance.

• Who manufactures the Model 1000 Electronic Clinical Thermometer and where are they located?

  The Model 1000 Electronic Clinical Thermometer is manufactured by Mon-A-Therm, Inc., located at the St. Louis Business Center, 500 S. Ewing Ave., St. Louis, MO 63103, United States, as listed in the device authorization records.

• What regulatory clearance does the Model 1000 Electronic Clinical Thermometer have and when was it granted?

  The Model 1000 Electronic Clinical Thermometer received FDA 510(k) clearance under submission K885187 on March 8, 1989, and was determined to be substantially equivalent to a legally marketed predicate device for general hospital use.