Models Qed-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load Adapter

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K954391 ↗

FDA Product Code

DRL

Models / Variants

Qed-6

6M

6H Defibrillator Analyzer With Optional Universal Pacemaker Load Adapter

Device Class

Class II

Regulation

21 CFR Part 870.5325

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Ida-4 and Ipt-Mc

  Class II

  FDA 510(k) K973609 Active Cleared 18 Dec 1997

• The Bio-Tek Uw-Ii

  Class II

  FDA 510(k) K862932 Active Cleared 25 Sep 1986

• ELX808 Automated Microplate Readers

  Class I

  FDA 510(k) K953710 Active Cleared 25 Oct 1995

• Bio-Tek Ear Oximeter

  Class II

  FDA 510(k) K810363 Active Cleared 27 Feb 1981

• ELX800UV

  Class I

  FDA 510(k) K953572 Active Cleared 19 Oct 1995

• Contourograph M-500

  Unclassified

  FDA 510(k) K800591 Active Cleared 2 Apr 1980

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