VivaSight-SL (TVT) system— 510(k) K181880

Substantially Equivalent

Etview , Ltd.

FDA 510(k) clearance K181880 for VivaSight-SL (TVT) system, Substantially Equivalent on 2018-11-29. Applicant: Etview , Ltd..

Clearance details

Applicant: Etview , Ltd.
Product code: Code BTR
Advisory panel: Anesthesiology
Date received: 2018-07-13
Decision date: 2018-11-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Misgav Business Park, IL

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Adverse events under product code BTR

product code BTR

Death: 92
Injury: 1,263
Malfunction: 7,475
Other: 2
Total: 8,832

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.