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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
Classification Namebone sonometer
Generic Namebone sonometer
Regulation Number892.1180
Applicant
BEAM-MED LTD
8 halapid str.
petach tikva 49170
PMA NumberP990035
Supplement NumberS004
Date Received09/25/2001
Decision Date11/30/2001
Product Code
MUA[ Registered Establishments with MUA ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AR RND NETWORKS LTD, JERUSALEM, ISREAL.
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