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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K981405
Device Name SYNERGY LT
Applicant
OXFORD INSTRUMENTS, PLC.
MANOR WAY
OLD WOKING , SURREY,  GB 9022 0JU
Applicant Contact JEFF HALL
Correspondent
OXFORD INSTRUMENTS, PLC.
MANOR WAY
OLD WOKING , SURREY,  GB 9022 0JU
Correspondent Contact JEFF HALL
Regulation Number882.1870
Classification Product Code
GWF  
Date Received04/20/1998
Decision Date 07/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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