MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE— 510(k) K992340

Substantially Equivalent

Masimo Corp.

FDA 510(k) clearance K992340 for MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE, Substantially Equivalent on 1999-10-08. Applicant: Masimo Corp..

Clearance details

Applicant: Masimo Corp.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1999-07-13
Decision date: 1999-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
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.