ANISEIKONIA INSPECTOR

Haploscope

OPTICAL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Optical Diagnostics, Inc. with the FDA for Aniseikonia Inspector.

Pre-market Notification Details

Device IDK013110
510k NumberK013110
Device Name:ANISEIKONIA INSPECTOR
ClassificationHaploscope
Applicant OPTICAL DIAGNOSTICS, INC. 490 MT. FURY CIRCLE SW Issaquah,  WA  98027
ContactJoyce De Wit
CorrespondentJoyce De Wit
OPTICAL DIAGNOSTICS, INC. 490 MT. FURY CIRCLE SW Issaquah,  WA  98027
Product CodeHJT  
CFR Regulation Number886.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-11
Decision Date2001-12-19
Summary:summary

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