Cleared Traditional

K061204 - MASIMO SET RADICAL 7 PULSE CO-OXIMETER (FDA 510(k) Clearance)

K061204 · Masimo Corporation · Anesthesiology device

Jul 2006

Decision

87d

Days

Class 2

Risk

K061204 is an FDA 510(k) clearance for the MASIMO SET RADICAL 7 PULSE CO-OXIMETER. 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 July 27, 2006, 87 days after receiving the submission on May 1, 2006.

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

Submission Details

510(k) Number	K061204 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 01, 2006
Decision Date	July 27, 2006
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF