GALIX WINTER


Device Classification Name

computer, diagnostic, programmable

510(k) Number K030145
Device Name GALIX WINTER
Original Applicant
GALIX BIOMEDICAL INSTRUMENTATION, INC.
2555 collins ave., c-5
miami beach, 
FL 
33140

Original Contact eduardo rey
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 01/15/2003
Decision Date 09/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No