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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Dr.
Lowell,  MA  01851
Applicant Contact MAYLIN TRUESDELL
Correspondent
Boston Scientific Corporation
55 Technology Dr.
Lowell,  MA  01851
Correspondent Contact MAYLIN TRUESDELL
Regulation Number870.2060
Classification Product Code
DRQ  
Date Received02/02/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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