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510(k) K900553

CONSTANT CURRENT STIMULATOR MODEL 022101 by Ep Technologies, Inc. — Product Code JOQ

K900553 is an FDA 510(k) premarket notification submitted by Ep Technologies, Inc. for the device "CONSTANT CURRENT STIMULATOR MODEL 022101". The FDA issued a decision of Substantially Equivalent on March 13, 1990. 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 Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1990
Date Received
February 6, 1990
Clearance Type
Traditional
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 Technologies, Inc.

  • K043257 — REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM (February 3, 2005)
  • K013349 — ASTRONOMER PLUS SYSTEM (April 9, 2002)
  • K003452 — POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D (December 7, 2000)
  • K940167 — DIAGNOSTIC I CATHETER (August 2, 1994)
  • K940168 — DIAGNOSTIC II CATHETER (July 27, 1994)
  • K924108 — TRACFINDER II (December 16, 1993)
  • K924109 — STEEROCATH II (December 16, 1993)
  • K913375 — TORQUE TUBE STEEROCATH(TM) (October 25, 1991)
  • K903880 — FRANZ(TM) STEERABLE COMBINATION CATHETER (October 12, 1990)
  • K900765 — STEEROCATH(TM) (May 7, 1990)

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)
  • 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)

FDA data resources