Bindex BI-100— 510(k) K152020
Substantially EquivalentBone Index Finland , Ltd.
FDA 510(k) clearance K152020 for Bindex BI-100, Substantially Equivalent on 2016-05-13. Applicant: Bone Index Finland , Ltd.. Device class: 2.
Clearance details
- Applicant
- Bone Index Finland , Ltd.
- Product code
- Code MUA
- Device class
- Class 2
- Regulation
- 21 CFR 892.1180
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Kuopio, FI
Recent devices under product code MUA
view allData sourced from openFDA. This site is unofficial and independent of the FDA.