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510(k) K961595

DEFIBRILLATOR ANALYZER, DELTA 1000 by Netech Corp. — Product Code DRL

K961595 is an FDA 510(k) premarket notification submitted by Netech Corp. for the device "DEFIBRILLATOR ANALYZER, DELTA 1000". The FDA issued a decision of Substantially Equivalent on October 29, 1996. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1996
Date Received
April 24, 1996
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 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)
  • K954391 — MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER (November 17, 1995)

FDA data resources