RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP

Camera, Ophthalmic, Ac-powered

CLARITY MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Clarity Medical Systems with the FDA for Retcam Portable Ophthalmic Imaging System, Model Rcp.

Pre-market Notification Details

Device IDK083771
510k NumberK083771
Device Name:RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP
ClassificationCamera, Ophthalmic, Ac-powered
Applicant CLARITY MEDICAL SYSTEMS 5775 WEST LAS POSITAS BLVD. SUITE 200 Pleasanton,  CA  94588 -4084
ContactGary A Seeger
CorrespondentGary A Seeger
CLARITY MEDICAL SYSTEMS 5775 WEST LAS POSITAS BLVD. SUITE 200 Pleasanton,  CA  94588 -4084
Product CodeHKI  
CFR Regulation Number886.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-18
Decision Date2009-01-30
Summary:summary

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