VITALSENS, AINGEAL, V-POD— 510(k) K110015

Substantially Equivalent

Intelesens Limited

FDA 510(k) clearance K110015 for VITALSENS, AINGEAL, V-POD, Substantially Equivalent on 2011-05-20. Applicant: Intelesens Limited.

Clearance details

Applicant: Intelesens Limited
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2011-01-03
Decision date: 2011-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, 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.