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

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..

Clearance details

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

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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.