Cleared Traditional

K213676 - Masimo Rad-G with Temperature (FDA 510(k) Clearance)

K213676 · Masimo Corporation · Anesthesiology device

Apr 2023

Decision

510d

Days

Class 2

Risk

K213676 is an FDA 510(k) clearance for the Masimo Rad-G with Temperature. 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 April 16, 2023, 510 days after receiving the submission on November 22, 2021.

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

Submission Details

510(k) Number	K213676 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 22, 2021
Decision Date	April 16, 2023
Days to Decision	510 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF