MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V— 510(k) K033998

Substantially Equivalent

Masimo Corp.

FDA 510(k) clearance K033998 for MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V, Substantially Equivalent on 2004-03-19. Applicant: Masimo Corp..

Clearance details

Applicant: Masimo Corp.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2003-12-24
Decision date: 2004-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.