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510(k) K083347

IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS by Fluke Biomedical — Product Code DRL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 24, 2008
Date Received
November 13, 2008
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 Fluke Biomedical

  • K121860 — ESA615 (January 25, 2013)
  • K121722 — ESA620 ELECTRICAL SAFETY ANALYZER (October 11, 2012)
  • K110429 — PROSIM 4, PROSIM 6, PROSIM 8 (September 2, 2011)
  • K103336 — MPS450 MULTIPARAMETER SIMULATOR (April 13, 2011)
  • K072114 — IMPULSE 6000D/7000DP (January 28, 2008)

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)
  • 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)
  • K954391 — MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER (November 17, 1995)