Device Classification Name |
amplifier and signal conditioner, transducer signal
|
510(k) Number |
K150235 |
Device Name |
CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels |
Applicant |
BOSTON SCIENTIFIC CORPORATION |
55 TECHNOLOGY DRIVE |
LOWELL,
MA
01851
|
|
Applicant Contact |
MAYLIN TRUESDELL |
Correspondent |
BOSTON SCIENTIFIC CORPORATION |
55 TECHNOLOGY DRIVE |
LOWELL,
MA
01851
|
|
Correspondent Contact |
MAYLIN TRUESDELL |
Regulation Number | 870.2060
|
Classification Product Code |
|
Date Received | 02/02/2015 |
Decision Date | 04/22/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|