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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K862339
Device Name MEVATRON KD-2
Applicant
SIEMENS MEDICAL LABORATORIES, INC.
2404 N. MAIN ST.
WALNUT CREEK,  CA  94596
Applicant Contact R. C NICOL
Correspondent
SIEMENS MEDICAL LABORATORIES, INC.
2404 N. MAIN ST.
WALNUT CREEK,  CA  94596
Correspondent Contact R. C NICOL
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/20/1986
Decision Date 10/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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