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510(k) K072200

STIMLAB by Micropace Pty, Ltd. — Product Code JOQ

K072200 is an FDA 510(k) premarket notification submitted by Micropace Pty, Ltd. for the device "STIMLAB". The FDA issued a decision of Substantially Equivalent on October 26, 2007. 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. Micropace Pty, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2007
Date Received
August 8, 2007
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 Micropace Pty, Ltd.

  • K253088 — OneStim-DUO Cardiac Stimulator (MP5003-4CO) (June 12, 2026)
  • K011826 — EPS320 CARDIAC STIMULATOR (January 24, 2002)

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)
  • 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)

FDA data resources