Stimlab

FDA 510(k) K072200 · Micropace Pty, Ltd.

Substantially Equivalent

510(k) numberK072200

Submission

Device name
Stimlab
Applicant
Micropace Pty, Ltd.
Canterbury, Nsw, AU
Received
August 8, 2007
Decision date
October 26, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOQ – Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1750
Specialty
Cardiovascular
Life-sustaining
Yes

Other 510(k)s with product code JOQ

510(k)DeviceApplicantDecision
K173439Bloom2 Programmable Electrophysiology StimulatorJOQ · Traditional Fischer Medical03/29/2018SE
K092913EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04JOQ · Special Ep Medsystems10/16/2009SE
K070743Z6 StimulatorJOQ · Traditional St Cardio Technologies, LLC07/02/2007SE
K041442EP-4 Clinical StimutatorJOQ · Special Ep Medsystems09/14/2004SE
K040207EP-4 Clinical StimulatorJOQ · Special Ep Medsystems02/27/2004SE
K011826EPS320 Cardiac StimulatorJOQ · Traditional Micropace Pty, Ltd.01/24/2002SE
K991293Epstim Electrophysiology Stimulator Control Program, Bloom DTU-215 Electrophysiology…JOQ · Traditional Fischer Medical Technologies, Inc.05/05/2000SE
K963579PACE-1A Cardiac StimulatorJOQ · Traditional Radionics, Inc.11/08/1996SE
K935590Ep Medical, Inc. EP-3 Clinical StimulatorJOQ · Traditional Ep Medical, Inc.05/05/1994SE
K900553Constant Current Stimulator Model 022101JOQ · Traditional Ep Technologies, Inc.03/13/1990SE

More from Ep Technologies, Inc.

510(k)DeviceDecision
K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional 06/12/2026SE
K011826EPS320 Cardiac StimulatorJOQ · Traditional 01/24/2002SE

Questions and answers

When was Stimlab cleared by the FDA?

Stimlab (K072200) received a 510(k) decision of Substantially Equivalent on October 26, 2007, 79 days after the submission was received.

What is the product code of K072200?

The FDA product code is JOQ – Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only), a Class II (moderate risk) device regulated under 21 CFR 870.1750.