K081659

Substantially Equivalent

RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L

Applicant: Masimo Corporation
Product code: DQA
Advisory panel: Cardiovascular
Date received: 2008-06-12
Decision date: 2008-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.