Cleared Special

PHILIPS DXL 12/16-LEAD ECG ALGORITHM

K132068 · Philips Medical Systems · Cardiovascular
Sep 2013
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K132068 is an FDA 510(k) clearance for the PHILIPS DXL 12/16-LEAD ECG ALGORITHM, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on September 26, 2013, 85 days after receiving the submission on July 3, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K132068 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2013
Decision Date September 26, 2013
Days to Decision 85 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340

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