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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Haploscope
510(k) Number K013110
Device Name ANISEIKONIA INSPECTOR
Applicant
Optical Diagnostics, Inc.
490 Mt. Fury Cir. SW
Issaquah,  WA  98027
Applicant Contact JOYCE DE WIT
Correspondent
Optical Diagnostics, Inc.
490 Mt. Fury Cir. SW
Issaquah,  WA  98027
Correspondent Contact JOYCE DE WIT
Regulation Number886.1340
Classification Product Code
HJT  
Date Received07/11/2001
Decision Date 12/19/2001
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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