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510(k) K092913

EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 by Ep Medsystems — Product Code JOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2009
Date Received
September 22, 2009
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

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  • K071028 — VIEWMATE SYSTEM (May 1, 2007)
  • K070706 — EP-WORKMATE (April 11, 2007)
  • K063277 — MAPMATE (November 30, 2006)
  • K063113 — EP-WORKMATE (October 27, 2006)
  • K041442 — EP-4 CLINICAL STIMUTATOR (September 14, 2004)
  • 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)
  • K072200 — STIMLAB (October 26, 2007)
  • K070743 — Z6 STIMULATOR (July 2, 2007)
  • K041442 — EP-4 CLINICAL STIMUTATOR (September 14, 2004)
  • 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)