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510(k) K110646

BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER by Beam-Med, Ltd. — Product Code MUA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 2011
Date Received
March 4, 2011
Clearance Type
Abbreviated
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

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