Visi Mobile Monitoring System, Visi Mobile Chest Sensor— 510(k) K142827

Name: FDA 510(k) clearance K142827
Creator: U.S. Food and Drug Administration
Published: 2015-07-20

Substantially Equivalent

Sotera Wireless, Inc.

FDA 510(k) clearance K142827 for Visi Mobile Monitoring System, Visi Mobile Chest Sensor, Substantially Equivalent on 2015-07-20. Applicant: Sotera Wireless, Inc.. Device class: 2.

Clearance details

Applicant: Sotera Wireless, Inc.
Product code: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2014-09-30
Decision date: 2015-07-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K180472 — ViSi Mobile Monitoring System2018-06-19
K152341 — ViSi Mobile Monitoring System2015-12-14
K150361 — ViSi Mobile Monitoring System2015-04-30
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Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.