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FDA 510(k) Application Details - K013391
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K013391
Device Name
Accelerator, Linear, Medical
Applicant
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
FEYERABENDSTRASSE 13-15
SCHWABMUNCHEN 86830 DE
Other 510(k) Applications for this Company
Contact
CHRISTIAN MULLER
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/15/2001
Decision Date
01/11/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K013391
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