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.
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.
Related Devices (Code: BTR)
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.
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Official Source
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