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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 K063270
Device Name RPM RESPIRATORY GATING SYSTEM
Applicant
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY M/S E-110
PALO ALTO,  CA  94304
Applicant Contact VY TRAN
Correspondent
VARIAN MEDICAL SYSTEMS, INC.
3100 HANSEN WAY M/S E-110
PALO ALTO,  CA  94304
Correspondent Contact VY TRAN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/30/2006
Decision Date 12/14/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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