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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 NameSUNLIGHT OMNISENSE 7000S ULTRASOUND BONE SONOMETER
Classification Namebone sonometer
Generic Nameultrasound bone sonometer
Regulation Number892.1180
ApplicantSUNLIGHT MEDICAL LTD.
PMA NumberP990035
Supplement NumberS003
Date Received08/10/2001
Decision Date05/24/2002
Product Code
MUA[ Registered Establishments with MUA ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
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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