Cleared Traditional

K180046 - Masimo Rad-97 and Accessories (FDA 510(k) Clearance)

K180046 · Masimo Corporation · Anesthesiology device

Oct 2018

Decision

288d

Days

Class 2

Risk

K180046 is an FDA 510(k) clearance for the Masimo Rad-97 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 October 23, 2018, 288 days after receiving the submission on January 8, 2018.

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

Submission Details

510(k) Number	K180046 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 08, 2018
Decision Date	October 23, 2018
Days to Decision	288 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF