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Ves-Temp Model VT1 Monoplace Cool/Heat System

by Reimers Engineering, Inc.

510(k) K873546

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 NumberK873546 Date29 Jan 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  • Withdrawn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
DWJ
Device Class
Class II
Regulation
21 CFR Part 870.5900
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM is a thermal regulating system classified under device class 2. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway under regulation number 870.5900.

The system is supplied by Reimers Engineering, Inc. and is intended for use in cardiovascular applications. It has been assigned product code DWJ and received FDA 510(k) clearance K873546 on January 29, 1988.

Questions

AI-generated answers, 1 Oct 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 VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM used for?

    The VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM is intended for use in cardiovascular applications as a thermal regulating system, as specified in its FDA 510(k) clearance documentation.

  • How is the VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM supplied and by whom?

    The system is supplied by Reimers Engineering, Inc., located at 6314-K Gravel Ave., Alexandria, VA 22310, as the manufacturer and applicant listed in the FDA 510(k) record.

  • What regulatory pathway was used to clear the VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM?

    The device was cleared via the traditional 510(k) pathway under regulation number 870.5900, based on a determination of substantial equivalence to a predicate device.