FDA 510(k)

ETView VivaSight-SL (TVT) system

K-Number: K152438 · 2016-02-25

Decision Date2016-02-25

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ETView VivaSight-SL (TVT) system is the device name listed in this FDA 510(k) record. The listed applicant is Etview , Ltd.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K152438. 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 ETView VivaSight-SL (TVT) system?

ETView VivaSight-SL (TVT) system is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Etview , Ltd.. The 510(k) number is K152438.

When did ETView VivaSight-SL (TVT) system receive FDA 510(k) clearance?

ETView VivaSight-SL (TVT) system received FDA 510(k) clearance on 2016-02-25, under 510(k) number K152438.

Who is the listed applicant for ETView VivaSight-SL (TVT) system?

The FDA 510(k) record lists Etview , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Etview , Ltd. as applicant

K181880VivaSight-SL (TVT) system K181886VivaSight-DL System K123853VIVASIGHT-DL SYSTEM K121028ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))K120334VIVA EB K113576DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM

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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.