CRM-114 COLOR VIDEO CAMERA

Endoscopic Video Imaging System/component, Gastroenterology-urology

UMI, INC.

The following data is part of a premarket notification filed by Umi, Inc. with the FDA for Crm-114 Color Video Camera.

Pre-market Notification Details

Device IDK830924
510k NumberK830924
Device Name:CRM-114 COLOR VIDEO CAMERA
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant UMI, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-22
Decision Date1983-04-18

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