510(k) K211350
K211350 is an FDA 510(k) premarket notification submitted by Bone Index Finland , Ltd. for the device "Bindex BI-2". The FDA issued a decision of Substantially Equivalent on April 29, 2022. The device falls under product code MUA (Bone Sonometer), a Class II device regulated under 21 CFR 892.1180. Bone Index Finland , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2022
- Date Received
- May 3, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bone Sonometer
- Device Class
- Class II
- Regulation Number
- 892.1180
- Review Panel
- RA
- Submission Type
A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal. Reclassified from class 3 pma to class 2 510(k) 892.1180 [docket no. Fda-2005-n-0346] reclassification of bone sonometers