FDA 510(k)

VivaSight-DL System

K-Number: K181886 · 2018-11-14

Decision Date2018-11-14

Product CodeCBI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

VivaSight-DL 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 2018-11-14 under 510(k) number K181886. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VivaSight-DL System?

VivaSight-DL System is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Etview , Ltd.. The 510(k) number is K181886.

When did VivaSight-DL System receive FDA 510(k) clearance?

VivaSight-DL System received FDA 510(k) clearance on 2018-11-14, under 510(k) number K181886.

Who is the listed applicant for VivaSight-DL 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 VivaSight-DL System?

The FDA product code for VivaSight-DL System is CBI.

Other records listing Etview , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181880VivaSight-SL (TVT) system K152438ETView VivaSight-SL (TVT) system

Related Devices (Code: CBI)

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.