4K UHD Camera System

Laparoscope, Gynecologic (and Accessories)

Scivita Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Scivita Medical Technology Co., Ltd. with the FDA for 4k Uhd Camera System.

Pre-market Notification Details

Device IDK200216
510k NumberK200216
Device Name:4K UHD Camera System
ClassificationLaparoscope, Gynecologic (and Accessories)
Applicant Scivita Medical Technology Co., Ltd. No.8, ZhongTian Xiang, Suzhou Industrial Park Suzhou,  CN 215000
ContactRuqin Wu
CorrespondentDiana Hong
Mid-Link Consulting Co, Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeHET  
Subsequent Product CodeEOB
Subsequent Product CodeFET
Subsequent Product CodeFGB
Subsequent Product CodeGCJ
Subsequent Product CodeHRX
Subsequent Product CodeNWB
CFR Regulation Number884.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-28
Decision Date2020-08-21

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