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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER
Generic NameBone sonometer
Regulation Number892.1180
ApplicantBEAM-MED LTD
8 HALAPID STR.
PETACH TIKVA 49170
PMA NumberP990035
Supplement NumberS003
Date Received08/10/2001
Decision Date05/24/2002
Reclassified Date 08/18/2008
Product Code MUA 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGING THE MANUFACTURING CALIBRATION SOFTWARE BY ADDING A NEW SPECIFICATION AND TEST METHODS THAT LIMITS THE AMPLITUDES OF THE THREE DIFFERENT PROBES WHICH ARE USED FOR THE APPROVED MULTIPLE SKELETAL SITES TO LESS THAN 520MV AND NORMALIZES THE PROBES TO PREDEFINED VALUES OF APPROXIMATELY 400MV.
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