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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
Generic NameBone sonometer
Regulation Number892.1180
ApplicantBeam-Med, Ltd.
8 Halapid St.
Petach Tikva 49170
PMA NumberP990035
Supplement NumberS004
Date Received09/25/2001
Decision Date11/30/2001
Reclassified Date08/18/2008
Product Code MUA 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Process 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 AR RND NETWORKS LTD, JERUSALEM, ISREAL.
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