MightySat -OTC— 510(k) K214115

Substantially Equivalent

Masimo Corporation

FDA 510(k) clearance K214115 for MightySat -OTC, Substantially Equivalent on 2024-01-31. Applicant: Masimo Corporation. Device class: 2.

Clearance details

Applicant: Masimo Corporation
Product code: Code OLK
Device class: Class 2
Regulation: 21 CFR 870.2700
Advisory panel: Cardiovascular
Date received: 2021-12-30
Decision date: 2024-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.