Device (Qed-6 +2 more) - 6M

No FDA recalls found in the data synced 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

See all devices from Bio-Tek Instruments, Inc. →