FDA 510(k) K214115, MightySat -OTC, Masimo Corporation
FDA 510(k) K214115, MightySat -OTC, Masimo Corporation
Device Name: MightySat -OTC
Manufacturer: Masimo Corporation
Device Classification Name: Pulse Oximeter For Over-The-Counter Use
Regulation Number: 870.2700
Classification Product Code: OLK
Date Received: 12/30/2021
Decision Date: 01/31/2024
Regulation Medical Specialty: Anesthesiology
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