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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K003367
Device Name ORION PLATINUM
Applicant
Srs Medical Systems, Inc.
14950 NE 95th St.
Redmond,  WA  98052
Applicant Contact LEE BRODY
Correspondent
Srs Medical Systems, Inc.
14950 NE 95th St.
Redmond,  WA  98052
Correspondent Contact LEE BRODY
Regulation Number882.5050
Classification Product Code
HCC  
Date Received10/30/2000
Decision Date 01/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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