Bindex BI-2— 510(k) K161971
Substantially EquivalentBone Index Finland , Ltd.
FDA 510(k) clearance K161971 for Bindex BI-2, Substantially Equivalent on 2017-01-09. 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
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