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510(k) K082798

DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 by Medicatech USA — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2008
Date Received
September 23, 2008
Clearance Type
Special
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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