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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
Classification Namebone sonometer
Generic Nameultrasonic bone densitometer
Regulation Number892.1180
ApplicantMCCUE PLC
PMA NumberP990016
Supplement NumberS001
Date Received10/12/2001
Decision Date11/08/2001
Product Code
MUA[ Registered Establishments with MUA ]
Advisory Committee Radiology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a software update from v4. 2. 0 to v4. 2. 1 and a new phantom (qa coupler).
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