Cleared Traditional

K193626 - Masimo Rad-97 Pulse CO-Oximeter and Accessories (FDA 510(k) Clearance)

K193626 · Masimo Corporation · Anesthesiology device

Aug 2020

Decision

228d

Days

Class 2

Risk

K193626 is an FDA 510(k) clearance for the Masimo Rad-97 Pulse CO-Oximeter and Accessories. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on August 10, 2020, 228 days after receiving the submission on December 26, 2019.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K193626 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 26, 2019
Decision Date	August 10, 2020
Days to Decision	228 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 870.2300