510(k) K180516
K180516 is an FDA 510(k) premarket notification submitted by Echolight S.P.A for the device "EchoS". The FDA issued a decision of Substantially Equivalent on October 19, 2018. The device falls under product code MUA (Bone Sonometer), a Class II device regulated under 21 CFR 892.1180. Echolight S.P.A has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2018
- Date Received
- February 27, 2018
- 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