Atlas FDA

EP-4 CLINICAL STIMUTATOR

FDA 510(k) clearance K041442 · decided 2004-09-14

Clearance details

K-number
K041442
Device name
EP-4 CLINICAL STIMUTATOR
Applicant
Ep Medsystems
Decision
Substantially Equivalent
Date received
2004-06-01
Decision date
2004-09-14
Days to decision
105 days
Clearance type
Special
Product code
JOQ
Device class
2
Regulation number
870.1750
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
West Berlin, NJ, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Ep Medsystems

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Bloom2 Programmable Electrophysiology Stimulator (K173439)Fischer Medical2018-03-29
EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 (K092913)Ep Medsystems2009-10-16
STIMLAB (K072200)Micropace Pty, Ltd.2007-10-26
Z6 STIMULATOR (K070743)St Cardio Technologies, LLC2007-07-02
EP-4 CLINICAL STIMULATOR (K040207)Ep Medsystems2004-02-27
EPS320 CARDIAC STIMULATOR (K011826)Micropace Pty, Ltd.2002-01-24
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR (K991293)Fischer Medical Technologies, Inc.2000-05-05
PACE-1A CARDIAC STIMULATOR (K963579)Radionics, Inc.1996-11-08
EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR (K935590)Ep Medical, Inc.1994-05-05
CONSTANT CURRENT STIMULATOR MODEL 022101 (K900553)Ep Technologies, Inc.1990-03-13
HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM (K893094)Heartware Intl. Corp.1989-10-02
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR (K861368)Medtronic Vascular1986-08-04

Recalls involving this device

RecordFirmDate
EP-4 Computerized Stimulator -- 2 channel and 4 channel. The product consists of a touchsc recall (Z-0914-06)EP Medsystems2006-05-31