HB 1000, Brugada Electrophysiology System

FDA 510(k) K893094 · Heartware Intl. Corp.

Substantially Equivalent

510(k) numberK893094

Submission

Device name
HB 1000, Brugada Electrophysiology System
Applicant
Heartware Intl. Corp.
New York, NY, US
Received
April 28, 1989
Decision date
October 2, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K072200StimlabJOQ · Traditional Micropace Pty, Ltd.10/26/2007SE
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

More from Ep Medical, Inc.

510(k)DeviceDecision
K932410Heartview(R) Coronary Angiograph Diagram/Report SyIZI · Traditional 12/13/1993SE
K933073Hearttrace Left Ventricular Analysis SoftwareIZI · Traditional 10/07/1993SE
K933058Hearttrack Quantitative Coronary Angiography SoftwIZI · Traditional 09/28/1993SE

Questions and answers

When was HB 1000, Brugada Electrophysiology System cleared by the FDA?

HB 1000, Brugada Electrophysiology System (K893094) received a 510(k) decision of Substantially Equivalent on October 2, 1989, 157 days after the submission was received.

What is the product code of K893094?

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.