Single-Use Flexible Rhinolaryngoscope

Nasopharyngoscope (flexible Or Rigid)

Hunan Vathin Medical Instrument Co., Ltd.

The following data is part of a premarket notification filed by Hunan Vathin Medical Instrument Co., Ltd. with the FDA for Single-use Flexible Rhinolaryngoscope.

Pre-market Notification Details

Device IDK221581
510k NumberK221581
Device Name:Single-Use Flexible Rhinolaryngoscope
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, Innovation And Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan,  CN 411100
ContactDu Jing
CorrespondentDu Jing
Hunan Vathin Medical Instrument Co., Ltd. 1/F, Building 12, Innovation And Entrepreneurship Service Ctr, No. 9 Chuanqi West Road Jiuhua Economic Dev. Zone Xiangtan,  CN 411100
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-01
Decision Date2022-11-18

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.