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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 K933558
Device Name ARM RADIATION BEAM SCANNER
Applicant
Advanced Radiation Measurements, Inc.
601 NE Emerson St.
Port St. Lucie,  FL  34983
Applicant Contact DANIEL NAVARRO
Correspondent
Advanced Radiation Measurements, Inc.
601 NE Emerson St.
Port St. Lucie,  FL  34983
Correspondent Contact DANIEL NAVARRO
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/21/1993
Decision Date 03/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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