Cleared Traditional

K051439 - LNOP BLUE OXIMETRY SENSOR (FDA 510(k) Clearance)

K051439 · Masimo Corporation · Anesthesiology device

Jul 2005

Decision

43d

Days

Class 2

Risk

K051439 is an FDA 510(k) clearance for the LNOP BLUE OXIMETRY SENSOR. 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 15, 2005, 43 days after receiving the submission on June 2, 2005.

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

Submission Details

510(k) Number	K051439 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 02, 2005
Decision Date	July 15, 2005
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF