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
|
|
Correspondent Contact |
NATALIE BENNINGTON |
Regulation Number | 870.1425
|
Classification Product Code |
|
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
|
|
|