K111378

Substantially Equivalent

OXIMETRY INTERFACE KIT

Applicant: Philips Respironics, Inc.
Product code: MNS
Advisory panel: Anesthesiology
Date received: 2011-05-17
Decision date: 2011-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

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.