Cleared Abbreviated

PHILIPS INTELLIVUE TCG10

K110474 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Anesthesiology
Sep 2011
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K110474 is an FDA 510(k) clearance for the PHILIPS INTELLIVUE TCG10, a Monitor, Carbon-dioxide, Cutaneous (Class II — Special Controls, product code LKD), submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on September 30, 2011, 224 days after receiving the submission on February 18, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2480.

Submission Details

510(k) Number K110474 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2011
Decision Date September 30, 2011
Days to Decision 224 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code LKD — Monitor, Carbon-dioxide, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2480

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