Ilumien Optis, Optis Integrated, Optis Mobile— 510(k) K183320

Substantially Equivalent

St. Jude Medical (Now Abbott Medical)

FDA 510(k) clearance K183320 for Ilumien Optis, Optis Integrated, Optis Mobile, Substantially Equivalent on 2019-04-02. Applicant: St. Jude Medical (Now Abbott Medical).

Clearance details

Applicant
St. Jude Medical (Now Abbott Medical)
Product code
Code NQQ
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
St. Paul, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.