Micro C Medical Imaging System, M01

System, X-ray, Mobile

OXOS Medical, Inc.

The following data is part of a premarket notification filed by Oxos Medical, Inc. with the FDA for Micro C Medical Imaging System, M01.

Pre-market Notification Details

Device IDK211473
510k NumberK211473
Device Name:Micro C Medical Imaging System, M01
ClassificationSystem, X-ray, Mobile
Applicant OXOS Medical, Inc. 1230 Peachtree Street NE Suite 300 Atlanta,  GA  30309
ContactEvan Ruff
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-05-12
Decision Date2021-06-04

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