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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 NameRAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL
Classification Nameanalyzer,medical image
Generic Nameanalyzer, medical image, chest x-ray
ApplicantRIVERAIN MEDICAL
PMA NumberP000041
Supplement NumberS003
Date Received11/18/2005
Decision Date07/27/2006
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at riverain medical group, miamisburg, ohio.
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