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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 NameMCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM
Classification Namebone sonometer
Generic Nameultrasonic bone densitometer
Regulation Number892.1180
ApplicantCOOPERSURGICAL, INC.
PMA NumberP990016
Supplement NumberS002
Date Received01/16/2002
Decision Date03/28/2002
Product Code
MUA[ Registered Establishments with MUA ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the cubaclinical data controller (data controller). The data controller is a hand-held control device that enables the user to operate the cubaclinical without the computer and the software for data analysis. The modifications to the bone sonometer consist of the integration of the data controller and associated software, simple replacement of the cubaclinical serial connector, and data controller operating instructions. The results are displayed on an lcd screen display and the printout shows a graphical display of patient data.
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