K214115

Substantially Equivalent

MightySat -OTC

Applicant: Masimo Corporation
Product code: OLK
Advisory panel: Cardiovascular
Date received: 2021-12-30
Decision date: 2024-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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