Home / 510(k) Clearances / K935590

510(k) K935590

EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR by Ep Medical, Inc. — Product Code JOQ

K935590 is an FDA 510(k) premarket notification submitted by Ep Medical, Inc. for the device "EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR". The FDA issued a decision of Substantially Equivalent on May 5, 1994. 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 Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1994
Date Received
November 18, 1993
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 Medical, Inc.

  • K933069 — MODEL EP-2 CLINICAL STIMULATOR (October 21, 1993)
  • K901320 — ABSORBENT, DISPOSABLE URINARY DRAINAGE BAG (January 25, 1991)

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)
  • K900553 — CONSTANT CURRENT STIMULATOR MODEL 022101 (March 13, 1990)

FDA data resources