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510(k) K991293

EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR by Fischer Medical Technologies, Inc. — Product Code JOQ

K991293 is an FDA 510(k) premarket notification submitted by Fischer Medical Technologies, Inc. for the device "EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR". The FDA issued a decision of Substantially Equivalent on May 5, 2000. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2000
Date Received
April 15, 1999
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 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)
  • 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