DeviceClearance

CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels— 510(k) K150235

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K150235 for CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels, Substantially Equivalent on 2015-04-22. 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
Download summary PDFView on FDA.gov ↗

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Recalls naming K150235

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150235.

Data sourced from openFDA. This site is unofficial and independent of the FDA.