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Medi-Therm

by Gaymar Industries, Inc.

510(k) K800812

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 NumberK800812 Date24 Apr 1980ClearedStatusActive

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  • Withdrawn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
DWJ
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Medi-Therm MTA6900 Series is a Thermal Regulating System (OpenFDA classification: DWJ) designed to regulate patient temperature through controlled heating or cooling. It employs two separate reservoirs for circulating heated or cooled solutions to maintain precise thermal management, supporting clinical applications requiring hyperthermia or hypothermia interventions.

This device is intended for use in clinical settings such as operating rooms, intensive care units, or emergency departments. Supplied as a reusable medical device, it requires proper calibration, maintenance, and adherence to manufacturer guidelines for safe operation. The Medi-Therm MTA6900 Series holds an FDA 510(k) clearance (K800812) under the Cardiovascular advisory committee, with regulatory classification as a Class II device. Storage and handling must comply with manufacturer instructions to ensure functionality and patient safety.

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