FDA 510(k)

VivaSight-SL (TVT) system

K-Number: K181880 · 2018-11-29

Decision Date2018-11-29

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

VivaSight-SL (TVT) system is a medical device manufactured by Etview , Ltd.. It received FDA 510(k) clearance on 2018-11-29 under approval number K181880. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VivaSight-SL (TVT) system?

VivaSight-SL (TVT) system is a medical device that received FDA 510(k) clearance on 2018-11-29. It is manufactured by Etview , Ltd.. The 510(k) number is K181880.

When was VivaSight-SL (TVT) system approved by the FDA?

VivaSight-SL (TVT) system received FDA 510(k) clearance on 2018-11-29, under approval number K181880.

What company makes VivaSight-SL (TVT) system?

VivaSight-SL (TVT) system is manufactured by Etview , Ltd..

What is the FDA product code for VivaSight-SL (TVT) system?

The FDA product code for VivaSight-SL (TVT) system is BTR.

Other Devices by Etview , Ltd.

K152438ETView VivaSight-SL (TVT) system K181886VivaSight-DL System

Related Devices (Code: BTR)

K152438ETView VivaSight-SL (TVT) systemEtview , Ltd. K161813Frova Intubating IntroducerWilliam Cook Europe Aps K160694Disposable Endotracheal tube, sterile, AccuCuffTianjin Medis Medical Device Co., Ltd. K171917Frova Intubating IntroducerCook Incorporated K172208NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded StyletNevap, Inc. K170234Endotracheal tube; Reinforced Endotracheal tubeZhanjiang Star Enterprise Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.