Cleared Special

K061329 - INFINITY MASIMO SET SP02 POD (FDA 510(k) Clearance)

K061329 · Draeger Medical Systems, Inc. · Anesthesiology device

Jul 2006

Decision

56d

Days

Class 2

Risk

K061329 is an FDA 510(k) clearance for the INFINITY MASIMO SET SP02 POD. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on July 7, 2006, 56 days after receiving the submission on May 12, 2006.

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

Submission Details

510(k) Number	K061329 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 12, 2006
Decision Date	July 07, 2006
Days to Decision	56 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF