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510(k) K152693

CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels by Boston Scientific Corporation — Product Code DRQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2015
Date Received
September 21, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Transducer Signal
Device Class
Class II
Regulation Number
870.2060
Review Panel
CV
Submission Type

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