EQUIVITAL— 510(k) K113054

Substantially Equivalent

Hidalgo Limited

FDA 510(k) clearance K113054 for EQUIVITAL, Substantially Equivalent on 2012-02-17. Applicant: Hidalgo Limited.

Clearance details

Applicant: Hidalgo Limited
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2011-10-13
Decision date: 2012-02-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Cambridge, GB

Download summary PDF View on FDA.gov ↗

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.