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510(k) K941404

IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER by Hogan & Hartson — Product Code DRL

K941404 is an FDA 510(k) premarket notification submitted by Hogan & Hartson for the device "IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER". The FDA issued a decision of Substantially Equivalent on June 29, 1994. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. Hogan & Hartson has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1994
Date Received
March 23, 1994
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 Hogan & Hartson

  • K974168 — COOPERSURGICAL INFRARED COAGULATOR (January 23, 1998)
  • K973849 — BIOABSORBABLE BANKART TACK (January 6, 1998)
  • K973162 — DUAL RADIATION TARGETING SYSTEM DRTS DRAPE (November 20, 1997)
  • K950169 — RIBOSOMAL P EIA TEST SYSTEM (May 23, 1996)
  • K942389 — TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (February 16, 1996)
  • K946216 — CARDIOLIPIN A EIA TEST SYSTEM (January 24, 1996)
  • K946217 — CARDIOLIPIN M EIA TEST SYSTEM (January 24, 1996)
  • K946215 — CARDIOLIPIN G EIA TEST SYSTEM (January 24, 1996)
  • K946186 — CHAL-2500 (August 14, 1995)
  • K941566 — COMPUSPEAK (June 30, 1995)

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