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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K023719
Device Name MP-1 MICRO PERIMETER
Applicant
Nidek Technologies Srl
Via Regia, 88
Vigonza (Padova),  IT 35010
Applicant Contact ALDO COCCHIGLIA
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact MARK JOB
Regulation Number886.1120
Classification Product Code
HKI  
Subsequent Product Code
HPT  
Date Received11/05/2002
Decision Date 12/23/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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