Cleared Traditional

PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph

K191738 · Philips Medical Systems · Cardiovascular
Sep 2020
Decision
459d
Days
Class 2
Risk

About This 510(k) Submission

K191738 is an FDA 510(k) clearance for the PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter 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 September 29, 2020, 459 days after receiving the submission on June 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K191738 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2019
Decision Date September 29, 2020
Days to Decision 459 days
Submission Type Traditional
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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