Device Classification Name |
amplifier and signal conditioner, transducer signal
|
510(k) Number |
K152693 |
Device Name |
CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels |
Applicant |
BOSTON SCIENTIFIC CORPORATION |
55 TECHNOLOGY DR |
LOWELL,
MA
01851
|
|
Applicant Contact |
MAYLIN TRUESDELL |
Correspondent |
BOSTON SCIENTIFIC CORPORATION |
55 TECHNOLOGY DR |
LOWELL,
MA
01851
|
|
Correspondent Contact |
MAYLIN TRUESDELL |
Regulation Number | 870.2060
|
Classification Product Code |
|
Date Received | 09/21/2015 |
Decision Date | 10/21/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|