MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES— 510(k) K091057

Substantially Equivalent

Masimo Corporation

FDA 510(k) clearance K091057 for MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES, Substantially Equivalent on 2009-07-09. Applicant: Masimo Corporation.

Clearance details

Applicant: Masimo Corporation
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2009-04-13
Decision date: 2009-07-09
Decision: Substantially Equivalent
Clearance type: Special
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.