Microlife Digital Infrared Ear Thermometer IR1DAI, IR1DB1, IR1DD1

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

510(k) Number

K003308 ↗

FDA Product Code

FLL

Device Class

Class II

Regulation

21 CFR Part 880.2910

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Microlife Digital Infrared Ear Thermometer, Model IR1DA1

  Class II

  FDA 510(k) K000969 Active Cleared 22 Aug 2000

• Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D

  Class II

  FDA 510(k) K080337 Active Cleared 13 May 2008

• Microlife Wrist Watch Blood Pressure Monitor, Model Bp-3BU1

  Class II

  FDA 510(k) K001182 Active Cleared 1 Aug 2000

• Microlife Upper Arm Automatic Blood Pressure Monitor, Model Bp-3BTO-1, with Optional Thermal Printer, Model Pr 1KA1

  Class II

  FDA 510(k) K013485 Active Cleared 17 Jan 2002

• Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)

  Class II

  FDA 510(k) K073398 Active Cleared 20 Dec 2007

• Microlife Electronic Peak Flow Monitor, Model Pf-100

  Class II

  FDA 510(k) K031024 Active Cleared 14 Nov 2003

See all devices from Microlife Corp. →

• What is the primary function of the Microlife Digital Infrared Ear Thermometer?

  This device is a clinical electronic thermometer designed to measure a patient's body temperature. It operates by utilizing a transducer that is coupled with an electronic signal amplification, conditioning, and display unit to provide accurate temperature readings.

• Which models are included in this thermometer series?

  The series includes three specific models: IR1DAI, IR1DB1, and IR1DD1. These models are all classified as clinical electronic thermometers intended for use in general hospital settings.

• Has this thermometer received regulatory clearance?

  Yes, the Microlife Digital Infrared Ear Thermometer models IR1DAI, IR1DB1, and IR1DD1 have received FDA 510(k) clearance under the number K003308. This indicates the device has been reviewed and cleared for clinical use.