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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Tremor
510(k) Number K971318
Device Name MM-1 MOVEMENT MONITOR
Applicant
Axon Instruments, Inc.
1101 Chess Dr.
Foster City,  CA  94404 -1102
Applicant Contact ANDREW L BLATZ
Correspondent
Axon Instruments, Inc.
1101 Chess Dr.
Foster City,  CA  94404 -1102
Correspondent Contact ANDREW L BLATZ
Regulation Number882.1950
Classification Product Code
GYD  
Date Received04/09/1997
Decision Date 07/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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