Cleared Traditional

K182887 - Masimo Rad-67 Pulse CO-Oximeter and Accessories (FDA 510(k) Clearance)

K182887 · Masimo Corporation · Anesthesiology device

Mar 2019

Decision

158d

Days

Class 2

Risk

K182887 is an FDA 510(k) clearance for the Masimo Rad-67 Pulse CO-Oximeter and Accessories. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on March 22, 2019, 158 days after receiving the submission on October 15, 2018.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K182887 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 15, 2018
Decision Date	March 22, 2019
Days to Decision	158 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF