M2376A PHILIPS DEVICE LINK SYSTEM— 510(k) K033680

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K033680 for M2376A PHILIPS DEVICE LINK SYSTEM, Substantially Equivalent on 2003-12-11. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2003-11-24
Decision date: 2003-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Boblingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.