Cleared Special

K063140 - RAINBOW ADHESIVE CO-OXIMETRY SENSORS (FDA 510(k) Clearance)

K063140 · Masimo Corporation · Anesthesiology device

Dec 2006

Decision

74d

Days

Class 2

Risk

K063140 is an FDA 510(k) clearance for the RAINBOW ADHESIVE CO-OXIMETRY SENSORS. 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 December 29, 2006, 74 days after receiving the submission on October 16, 2006.

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

Submission Details

510(k) Number	K063140 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 16, 2006
Decision Date	December 29, 2006
Days to Decision	74 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF