MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES— 510(k) K011851

Substantially Equivalent

Masimo Corp.

FDA 510(k) clearance K011851 for MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, Substantially Equivalent on 2001-07-11. Applicant: Masimo Corp..

Clearance details

Applicant: Masimo Corp.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2001-06-13
Decision date: 2001-07-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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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.