CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)


Device Classification Name

computer, diagnostic, programmable

510(k) Number K072202
Device Name CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)
Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, 
CA 
91765

Applicant Contact natalie bennington
Correspondent
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd.
diamond bar, 
CA 
91765

Correspodent Contact natalie bennington
Regulation Number 870.1425
Classification Product Code
DQK  
Date Received 08/08/2007
Decision Date 11/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No