Cleared Traditional

K090165 - RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 (FDA 510(k) Clearance)

K090165 · Masimo Corporation · Anesthesiology device

Jul 2009

Decision

168d

Days

Class 2

Risk

K090165 is an FDA 510(k) clearance for the RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20. 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 9, 2009, 168 days after receiving the submission on January 22, 2009.

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

Submission Details

510(k) Number	K090165 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 22, 2009
Decision Date	July 09, 2009
Days to Decision	168 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF