Cleared Traditional

K042536 - MASIMO SET RAD 57 PULSE CO-OXIMETER (FDA 510(k) Clearance)

K042536 · Masimo Corporation · Anesthesiology device

Jan 2005

Decision

121d

Days

Class 2

Risk

K042536 is an FDA 510(k) clearance for the MASIMO SET RAD 57 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 January 19, 2005, 121 days after receiving the submission on September 20, 2004.

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

Submission Details

510(k) Number	K042536 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 20, 2004
Decision Date	January 19, 2005
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF