PACE-1A Cardiac Stimulator

Q: What is the product code of K963579?

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) K963579 · Radionics, Inc.

Substantially Equivalent

510(k) numberK963579

Submission

Device name: PACE-1A Cardiac Stimulator
Applicant: Radionics, Inc.
Burlington, MA, US
Received: September 6, 1996
Decision date: November 8, 1996
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)	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
K935590	Ep Medical, Inc. EP-3 Clinical StimulatorJOQ · Traditional	Ep Medical, Inc.	05/05/1994SE
K900553	Constant Current Stimulator Model 022101JOQ · Traditional	Ep Technologies, Inc.	03/13/1990SE

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K000057	Radionics Lumboperitoneal ShuntJXG · Traditional	03/20/2000SE
K993594	Conformax MMLC VR1IYE · Special	12/15/1999SE
K991399	Radionics Microelectrode KitGXI · Traditional	09/21/1999SE

Questions and answers

When was PACE-1A Cardiac Stimulator cleared by the FDA?

PACE-1A Cardiac Stimulator (K963579) received a 510(k) decision of Substantially Equivalent on November 8, 1996, 63 days after the submission was received.

What is the product code of K963579?

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.