Atlas FDA

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

FDA 510(k) clearance K150235 · decided 2015-04-22

Clearance details

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
Decision
Substantially Equivalent
Date received
2015-02-02
Decision date
2015-04-22
Days to decision
79 days
Clearance type
Special
Product code
DRQ
Device class
2
Regulation number
870.2060
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Lowell, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware recall (Z-1817-2015)Boston Scientific Corporation2015-06-18

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