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T824 Temperature Monitor

by Bio-Logic Devices

510(k) K880914

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880914 Date11 May 1988ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HCC
Device Class
Class II
Regulation
21 CFR Part 882.5050
Advisory Committee
Neurology
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 T824 Temperature Monitor is a device, biofeedback device used in neurology. It is substantially equivalent to other devices and has a device class of 2.

The T824 Temperature Monitor is supplied with an FDA 510K authorization, K880914, and has a product code of HCC. It is classified under regulation 882.5050 and has a traditional clearance type. The device was cleared on May 11, 1988.

Other devices from Bio-Logic Devices

Questions

AI-generated answers, 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.

  • What is the T824 Temperature Monitor used for?

    The T824 Temperature Monitor is a biofeedback device used in neurology to monitor temperature as part of neurological assessment or therapy, based on its classification and intended use as a biofeedback device in that specialty.

  • How is the T824 Temperature Monitor supplied and authorized?

    The T824 Temperature Monitor is supplied with FDA 510(k) authorization under K880914, which granted substantial equivalence to a predicate device, and it is classified under product code HCC and regulation 882.5050.

  • Is the T824 Temperature Monitor a single-use or reusable device?

    The device data does not specify whether the T824 Temperature Monitor is single-use or reusable; therefore, no determination can be made about its reusability based solely on the provided information.

  • What regulatory pathway was used for the T824 Temperature Monitor?

    The T824 Temperature Monitor received clearance through the traditional FDA 510(k) pathway, as indicated by its clearance_type of 'Traditional' and decision_code of 'SESE' (Substantially Equivalent).

  • What class is the T824 Temperature Monitor and what regulation does it fall under?

    The T824 Temperature Monitor is classified as a device class 2 product and falls under regulation 882.5050, which governs biofeedback devices in neurology.