510(k) K080495— SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3

Substantially Equivalent

Philips Medical Systems

Clearance details

Applicant: Philips Medical Systems
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2008-02-22
Decision date: 2008-03-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

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.