Endotracheal Tube

Tube, Tracheal (w/wo Connector)

Tianjin Medis Medical Device Co., Ltd.

The following data is part of a premarket notification filed by Tianjin Medis Medical Device Co., Ltd. with the FDA for Endotracheal Tube.

Pre-market Notification Details

Device IDK190274
510k NumberK190274
Device Name:Endotracheal Tube
ClassificationTube, Tracheal (w/wo Connector)
Applicant Tianjin Medis Medical Device Co., Ltd. No. 15-A, Saida One Avenue, Xiqing Economic Development Area Tainjin,  CN 300385
ContactYongzhi Wu
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai,  CN 200120
Product CodeBTR  
CFR Regulation Number868.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-08
Decision Date2019-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16920687303656 K190274 000
16920687303632 K190274 000
16920687303625 K190274 000
16920687303618 K190274 000
16920687303595 K190274 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.