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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nystagmograph
510(k) Number K982103
Device Name ULMER (VNG) VIDEO NYSTAGMOGRAPH
Applicant
SYNAPSYS, INC.
1400 MAIN ST.
LOUISVILLE,  CO  80027
Applicant Contact VERA BUFFALOE
Correspondent
SYNAPSYS, INC.
1400 MAIN ST.
LOUISVILLE,  CO  80027
Correspondent Contact VERA BUFFALOE
Regulation Number882.1460
Classification Product Code
GWN  
Date Received06/15/1998
Decision Date 09/11/1998
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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