Ep Medical, Inc. EP-3 Clinical Stimulator

Q: What is the product code of K935590?

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.

FDA 510(k) K935590 · Ep Medical, Inc.

Substantially Equivalent

510(k) numberK935590

Submission

Device name: Ep Medical, Inc. EP-3 Clinical Stimulator
Applicant: Ep Medical, Inc.
Budd Lake, NJ, US
Received: November 18, 1993
Decision date: May 5, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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)	Device	Applicant	Decision
K173439	Bloom2 Programmable Electrophysiology StimulatorJOQ · Traditional	Fischer Medical	03/29/2018SE
K092913	EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04JOQ · Special	Ep Medsystems	10/16/2009SE
K072200	StimlabJOQ · Traditional	Micropace Pty, Ltd.	10/26/2007SE
K070743	Z6 StimulatorJOQ · Traditional	St Cardio Technologies, LLC	07/02/2007SE
K041442	EP-4 Clinical StimutatorJOQ · Special	Ep Medsystems	09/14/2004SE
K040207	EP-4 Clinical StimulatorJOQ · Special	Ep Medsystems	02/27/2004SE
K011826	EPS320 Cardiac StimulatorJOQ · Traditional	Micropace Pty, Ltd.	01/24/2002SE
K991293	Epstim Electrophysiology Stimulator Control Program, Bloom DTU-215 Electrophysiology…JOQ · Traditional	Fischer Medical Technologies, Inc.	05/05/2000SE
K963579	PACE-1A Cardiac StimulatorJOQ · Traditional	Radionics, Inc.	11/08/1996SE
K900553	Constant Current Stimulator Model 022101JOQ · Traditional	Ep Technologies, Inc.	03/13/1990SE

More from Ep Technologies, Inc.

510(k)	Device	Decision
K933069	Model EP-2 Clinical StimulatorDTA · Traditional	10/21/1993SE
K901320	Absorbent, Disposable Urinary Drainage BagKNX · Traditional	01/25/1991SE

Questions and answers

When was Ep Medical, Inc. EP-3 Clinical Stimulator cleared by the FDA?

Ep Medical, Inc. EP-3 Clinical Stimulator (K935590) received a 510(k) decision of Substantially Equivalent on May 5, 1994, 168 days after the submission was received.

What is the product code of K935590?

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.