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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 K070231
Device Name ORION
Applicant
Nidek Technologies Srl
Via Dell Artigianato, 6/A
Albignasego (Padova),  IT 35020
Applicant Contact ALDO COCCHIGLIA
Correspondent
Nidek Technologies Srl
Via Dell Artigianato, 6/A
Albignasego (Padova),  IT 35020
Correspondent Contact ALDO COCCHIGLIA
Regulation Number886.1120
Classification Product Code
HKI  
Date Received01/24/2007
Decision Date 04/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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