Cleared Traditional

K111403 - MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES (FDA 510(k) Clearance)

K111403 · Masimo Corporation · Anesthesiology device

Dec 2011

Decision

225d

Days

Class 2

Risk

K111403 is an FDA 510(k) clearance for the MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES. 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 30, 2011, 225 days after receiving the submission on May 19, 2011.

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

Submission Details

510(k) Number	K111403 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 19, 2011
Decision Date	December 30, 2011
Days to Decision	225 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF