CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels— 510(k) K152693

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K152693 for CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels, Substantially Equivalent on 2015-10-21. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant
Boston Scientific Corporation
Product code
Code DRQ
Device class
Class 2
Regulation
21 CFR 870.2060
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Lowell, MA, US
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