CMDR 2C (Multiple Models)

System, X-ray, Mobile

MinXray, Inc

The following data is part of a premarket notification filed by Minxray, Inc with the FDA for Cmdr 2c (multiple Models).

Pre-market Notification Details

Device IDK201575
510k NumberK201575
Device Name:CMDR 2C (Multiple Models)
ClassificationSystem, X-ray, Mobile
Applicant MinXray, Inc 3611 Commercial Ave Northbrook,  IL  60062
ContactKeith Kretchmer
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeIZL  
Subsequent Product CodeLLZ
Subsequent Product CodeMQB
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-11
Decision Date2020-07-08

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