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510(k) K934254

IMPULSE 3000 DEFIBRILLATOR ANALYZER by Dynatech/Nevada, Inc. — Product Code DRL

K934254 is an FDA 510(k) premarket notification submitted by Dynatech/Nevada, Inc. for the device "IMPULSE 3000 DEFIBRILLATOR ANALYZER". The FDA issued a decision of Substantially Equivalent on November 23, 1993. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. Dynatech/Nevada, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1993
Date Received
August 31, 1993
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 Dynatech/Nevada, Inc.

  • K942546 — CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER (January 27, 1995)
  • K935817 — MEDSIM 300 PATIENT SIMULATOR (January 18, 1994)
  • K897074 — MODEL 215M PATIENT SIMULATOR (May 17, 1990)
  • K897029 — MODEL ECG100 SIMULATOR (April 26, 1990)
  • K897096 — MODEL 404A I.V. INFUSION PUMP ANALYZER (March 15, 1990)

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