CellChek 20 Rc

System, Image Management, Ophthalmic

Konan Medical, Inc.

The following data is part of a premarket notification filed by Konan Medical, Inc. with the FDA for Cellchek 20 Rc.

Pre-market Notification Details

Device IDK203244
510k NumberK203244
Device Name:CellChek 20 Rc
ClassificationSystem, Image Management, Ophthalmic
Applicant Konan Medical, Inc. 10-29, Miyanishicho Nishinomiya,  JP 662-0976
ContactRuna Emura
CorrespondentAlan Donald
Matrix Medical Consulting, INC. 8880 Rio San Diego Drive Suite 800 San Diego,  CA  92108
Product CodeNFJ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-03
Decision Date2021-06-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04582275250657 K203244 000

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