SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF— 510(k) K120125

Substantially Equivalent

Ge Medical Systems Information Technologies, Inc.

FDA 510(k) clearance K120125 for SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF, Substantially Equivalent on 2012-10-03. Applicant: Ge Medical Systems Information Technologies, Inc..

Clearance details

Applicant: Ge Medical Systems Information Technologies, Inc.
Product code: Code DXQ
Advisory panel: Cardiovascular
Date received: 2012-01-17
Decision date: 2012-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

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