Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K003362 |
Device Name |
ASTRONOMER+WITH SLD |
Applicant |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
ANDREA J BOUMIS |
Correspondent |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
ANDREA J BOUMIS |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 10/27/2000 |
Decision Date | 03/01/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|