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Compressor Mini, 115 V, Model 64 81 779 EH81E

by Siemens Elema AB

510(k) K023354

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK023354 Date5 Sep 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0848-2014 FDA Class II initiated 5 Dec 2013

    Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.

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  • Withdrawn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
BTI
Device Class
Class II
Regulation
21 CFR Part 868.6250
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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