Ilumien Optis, Optis Integrated, Optis Mobile— 510(k) K183320
Substantially EquivalentSt. 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). Device class: 2.
Clearance details
- Applicant
- St. Jude Medical (Now Abbott Medical)
- Product code
- Code NQQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code NQQ
view allMore clearances from St. Jude Medical (Now Abbott Medical)
view allData sourced from openFDA. This site is unofficial and independent of the FDA.