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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 K050098
Device Name DDAT OMT
Applicant
DDAT(UK) LTD
91 CLIDDESDEN ROAD
BASINGSTOKE, HAMPSHIRE,  GB RG21 3EY
Applicant Contact PETER LIOYD
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number882.1460
Classification Product Code
GWN  
Date Received01/18/2005
Decision Date 05/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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