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510(k) K041442

EP-4 CLINICAL STIMUTATOR by Ep Medsystems — Product Code JOQ

K041442 is an FDA 510(k) premarket notification submitted by Ep Medsystems for the device "EP-4 CLINICAL STIMUTATOR". The FDA issued a decision of Substantially Equivalent on September 14, 2004. The device falls under product code JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)), a Class II device regulated under 21 CFR 870.1750. Ep Medsystems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2004
Date Received
June 1, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Device Class
Class II
Regulation Number
870.1750
Review Panel
CV
Submission Type

Other clearances by Ep Medsystems

  • K092913 — EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 (October 16, 2009)
  • K073709 — MODIFICATION TO VIEWMATE SYSTEM (March 11, 2008)
  • K071028 — VIEWMATE SYSTEM (May 1, 2007)
  • K070706 — EP-WORKMATE (April 11, 2007)
  • K063277 — MAPMATE (November 30, 2006)
  • K063113 — EP-WORKMATE (October 27, 2006)
  • K033963 — EP DEFLECTABLE CATHETERS (April 15, 2004)
  • K040207 — EP-4 CLINICAL STIMULATOR (February 27, 2004)
  • K031066 — VIEWMATE ULTRASOUND IMAGING SYSTEM (October 17, 2003)
  • K032225 — EP-WORKMATE WITH RPM SYSTEM (August 20, 2003)

Other clearances for product code JOQ

  • K173439 — Bloom2 Programmable Electrophysiology Stimulator (March 29, 2018)
  • K092913 — EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 (October 16, 2009)
  • K072200 — STIMLAB (October 26, 2007)
  • K070743 — Z6 STIMULATOR (July 2, 2007)
  • K040207 — EP-4 CLINICAL STIMULATOR (February 27, 2004)
  • K011826 — EPS320 CARDIAC STIMULATOR (January 24, 2002)
  • K991293 — EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIO (May 5, 2000)
  • K963579 — PACE-1A CARDIAC STIMULATOR (November 8, 1996)
  • K935590 — EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR (May 5, 1994)
  • K900553 — CONSTANT CURRENT STIMULATOR MODEL 022101 (March 13, 1990)

FDA data resources