Cleared Special

K121912 - E1 EAR SENSORS (FDA 510(k) Clearance)

K121912 · Masimo Corporation · Anesthesiology device

Jul 2012

Decision

22d

Days

Class 2

Risk

K121912 is an FDA 510(k) clearance for the E1 EAR 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 July 24, 2012, 22 days after receiving the submission on July 2, 2012.

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

Submission Details

510(k) Number	K121912 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 02, 2012
Decision Date	July 24, 2012
Days to Decision	22 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF