FDA 510(k) Premarket Notification K201432: Masimo O3 Regional Oximeter System

Submission Details & Decision

Normalized public record details for 510(k) notification K201432.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K201432

Applicant / Sponsor

Masimo Corporation

Device Name

Masimo O3 Regional Oximeter System

Product Code

MUD

Decision Date

2020-08-29

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2020-06-01

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