Cleared Traditional

K053477 - MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS (FDA 510(k) Clearance)

K053477 · Masimo Corporation · Anesthesiology device

Mar 2006

Decision

92d

Days

Class 2

Risk

K053477 is an FDA 510(k) clearance for the MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS. 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 16, 2006, 92 days after receiving the submission on December 14, 2005.

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

Submission Details

510(k) Number	K053477 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 14, 2005
Decision Date	March 16, 2006
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF