K120125

Substantially Equivalent

SOFT-CUF, CLASSIC-CUF, DURA-CUF, SENSA-CUF

Applicant: Ge Medical Systems Information Technologies, Inc.
Product 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

Download summary PDF View on FDA.gov ↗

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