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510(k) K904159

DEFIBRILLATOR ANALYZER MODEL QED-5 by Bio-Tek Instruments, Inc. — Product Code DRL

K904159 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "DEFIBRILLATOR ANALYZER MODEL QED-5". The FDA issued a decision of Substantially Equivalent on March 18, 1991. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1991
Date Received
September 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Defibrillator
Device Class
Class II
Regulation Number
870.5325
Review Panel
CV
Submission Type

Other clearances by Bio-Tek Instruments, Inc.

  • K973609 — IDA-4 AND IPT-MC (December 18, 1997)
  • K971273 — INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF (October 8, 1997)
  • K961862 — MODELS IDA-2 PLUS AND IPT-1 (February 26, 1997)
  • K954391 — MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER (November 17, 1995)
  • K953710 — ELX808 AUTOMATED MICROPLATE READERS (October 25, 1995)
  • K953572 — ELX800UV (October 19, 1995)
  • K950104 — ELX800 AND EL800 AUTOMATED MICROPLATE READERS (March 21, 1995)
  • K942923 — CERES 900C & CERES UV900C (February 6, 1995)
  • K944257 — LIONHEART 3 MULTI-PARAMETER SIMULATOR (September 21, 1994)
  • K933519 — INDEX SPO2 SIMULATOR (September 1, 1994)

Other clearances for product code DRL

  • K190437 — Delta 3300 (August 28, 2019)
  • K182905 — UniPulse (December 14, 2018)
  • K153210 — Defibrillator Analyzer Variable Load (December 21, 2015)
  • K110192 — DEFIBRILLATOR ANALYZER - DA-2006P (February 8, 2011)
  • K083347 — IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (December 24, 2008)
  • K072114 — IMPULSE 6000D/7000DP (January 28, 2008)
  • K062099 — PHASE 3, MODEL DT-1 (January 25, 2007)
  • K030547 — MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE (July 11, 2003)
  • K963190 — QA-40M DEFIBRILLATOR TESTER (July 1, 1997)
  • K961595 — DEFIBRILLATOR ANALYZER, DELTA 1000 (October 29, 1996)

FDA data resources