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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name x-ray, tomography, computed, dental
510(K) Number K122018
Model OP300-1
Device Name OP300
Applicant
PALODEX GROUP OY
nahkelantie 160
tuusula, 
Contact matti tulikoura
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/10/2012
Decision Date 12/10/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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