MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS— 510(k) K120657

Substantially Equivalent

Masimo Corporation

FDA 510(k) clearance K120657 for MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS, Substantially Equivalent on 2012-09-19. Applicant: Masimo Corporation.

Clearance details

Applicant: Masimo Corporation
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2012-03-05
Decision date: 2012-09-19
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.