EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR


Device Classification Name

generator, pulse, pacemaker, external programmable

510(k) Number K991293
Device Name EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR
Applicant
FISCHER MEDICAL TECHNOLOGIES, INC.
12300 north grant
denver, 
CO 
80241

Applicant Contact ronald shores
Correspondent
FISCHER MEDICAL TECHNOLOGIES, INC.
12300 north grant
denver, 
CO 
80241

Correspodent Contact ronald shores
Regulation Number 870.1750
Classification Product Code
JOQ  
Date Received 04/15/1999
Decision Date 05/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls