Cleared Traditional

DISPOSABLE SPO2 SENSOR M1134A

K091572 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Anesthesiology
Sep 2009
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K091572 is an FDA 510(k) clearance for the DISPOSABLE SPO2 SENSOR M1134A, a Oximeter (Class II — Special Controls, product code DQA), submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on September 22, 2009, 112 days after receiving the submission on June 2, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K091572 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2009
Decision Date September 22, 2009
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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