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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.
 
DeviceOMNISENSE 7000S ULTRASOUND BONE SONOMETER
Generic NameBone sonometer
Regulation Number892.1180
ApplicantBeam-Med, Ltd.
8 Halapid St.
Petach Tikva 49170
PMA NumberP990035
Supplement NumberS005
Date Received12/21/2001
Decision Date11/17/2003
Reclassified Date08/18/2008
Product Code MUA 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZICON LTD., PETAH-TIKVA, ISRAEL.
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