Skip to content

Diatek 600 Thermometer System

by Diatek, Inc. 510(k)

Active United States

510(k) K833568

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK833568 Date10 Jan 1984ClearedStatusActive

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  • Withdrawn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
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Diatek 600 Thermometer System is a portable instrument for measuring patient temperatures. It features an LCD readout with backlight, interchangeable probes, disposable probe covers, disposable batteries, and self-calibration/test capability.

The device is supplied as a reusable system with disposable components such as probe covers and batteries. It is intended for use in general hospital settings and has received FDA 510(k) clearance under product code FLL, with K-number K833568.

Other devices from Diatek, Inc.

See all devices from Diatek, Inc. →

Questions

AI-generated answers, 22 Sep 2026

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

  • What is the Diatek 600 Thermometer System used for?

    The Diatek 600 Thermometer System is a portable instrument designed for measuring patient temperatures in general hospital settings, featuring an LCD readout with backlight and interchangeable probes for flexible clinical use.

  • How is the Diatek 600 Thermometer System supplied and what components are disposable?

    The device is supplied as a reusable system with disposable components including probe covers and batteries, allowing the main unit to be reused while maintaining hygiene through single-use disposables.

  • Does the Diatek 600 Thermometer System have self-calibration capability?

    Yes, the Diatek 600 Thermometer System includes self-calibration and test capability, enabling users to verify device accuracy without external tools, supporting reliable temperature measurements in clinical environments.