CLEARSIGN II Amplifier, 40 Channels, CLEARSIGN II Amplifier, 80 Channels, CLEARSIGN II Amplifier, 120 Channels, CLEARSIGN II Amplifer, 160 Channels

Amplifier And Signal Conditioner, Transducer Signal

BOSTON SCIENTIFIC CORPORATION

The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Clearsign Ii Amplifier, 40 Channels, Clearsign Ii Amplifier, 80 Channels, Clearsign Ii Amplifier, 120 Channels, Clearsign Ii Amplifer, 160 Channels.

Pre-market Notification Details

Device IDK150235
510k NumberK150235
Device Name:CLEARSIGN II Amplifier, 40 Channels, CLEARSIGN II Amplifier, 80 Channels, CLEARSIGN II Amplifier, 120 Channels, CLEARSIGN II Amplifer, 160 Channels
ClassificationAmplifier And Signal Conditioner, Transducer Signal
Applicant BOSTON SCIENTIFIC CORPORATION 55 TECHNOLOGY DRIVE Lowell,  MA  01851
ContactMaylin Truesdell
CorrespondentMaylin Truesdell
BOSTON SCIENTIFIC CORPORATION 55 TECHNOLOGY DRIVE Lowell,  MA  01851
Product CodeDRQ  
CFR Regulation Number870.2060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-02
Decision Date2015-04-22
Summary:summary

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