Cleared Traditional

Cardiac Workstation (5000); Cardiac Workstation (7000)

K241556 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular
Dec 2024
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K241556 is an FDA 510(k) clearance for the Cardiac Workstation (5000); Cardiac Workstation (7000), a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Philips Medizin Systeme B?blingen GmbH (Boblingen, DE). The FDA issued a Cleared decision on December 17, 2024, 200 days after receiving the submission on May 31, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K241556 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2024
Decision Date December 17, 2024
Days to Decision 200 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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