SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR— 510(k) K120132

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K120132 for SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR, Substantially Equivalent on 2012-02-14. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2012-01-17
Decision date: 2012-02-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.