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510(k) K080582

MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA by Medicatech USA — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2008
Date Received
March 3, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

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