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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 K843004
Device Name SERVO MED NYSTAGMOGRAPH NG-1
Applicant
SERVO MED, INC.
600 STEAMBOAT ROAD
GREENWICH,  CT  06830 -
Applicant Contact HIGHLEEN REYNOLDS
Correspondent
SERVO MED, INC.
600 STEAMBOAT ROAD
GREENWICH,  CT  06830 -
Correspondent Contact HIGHLEEN REYNOLDS
Regulation Number882.1460
Classification Product Code
GWN  
Date Received07/30/1984
Decision Date 10/30/1984
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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