GALIX PACESTAR


Device Classification Name

pulse-generator, pacemaker, external

510(k) Number K023080
Device Name GALIX PACESTAR
Original Applicant
GALIX BIOMEDICAL INSTRUMENTATION, INC.
2555 collins ave., c-5
miami beach, 
FL 
33140

Original Contact jordan gavrielides
Regulation Number 870.3600
Classification Product Code
DTE  
Date Received 09/17/2002
Decision Date 06/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No