Cleared Special

Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph

K210560 · Philips Medical Systems · Cardiovascular
Jun 2021
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K210560 is an FDA 510(k) clearance for the Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Philips Medical Systems (Shanghai, CN). The FDA issued a Cleared decision on June 30, 2021, 125 days after receiving the submission on February 25, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K210560 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2021
Decision Date June 30, 2021
Days to Decision 125 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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