Cleared Special

K062605 - PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T (FDA 510(k) Clearance)

K062605 · Philips Medical Systems · Anesthesiology device

Nov 2006

Decision

65d

Days

Class 2

Risk

K062605 is an FDA 510(k) clearance for the PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on November 9, 2006, 65 days after receiving the submission on September 5, 2006.

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

Submission Details

510(k) Number	K062605 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 05, 2006
Decision Date	November 09, 2006
Days to Decision	65 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF