SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8— 510(k) K103652

Substantially Equivalent

Philips Medical Systesms

FDA 510(k) clearance K103652 for SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8, Substantially Equivalent on 2011-01-13. Applicant: Philips Medical Systesms.

Clearance details

Applicant: Philips Medical Systesms
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2010-12-14
Decision date: 2011-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

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.