Cleared Traditional

Telemetry Monitor 5500 Release 4.0 (867232)

K242962 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular
May 2025
Decision
222d
Days
Class 2
Risk

About This 510(k) Submission

K242962 is an FDA 510(k) clearance for the Telemetry Monitor 5500 Release 4.0 (867232), a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Philips Medizin Systeme B?blingen GmbH (B?blingen, DE). The FDA issued a Cleared decision on May 5, 2025, 222 days after receiving the submission on September 25, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K242962 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2024
Decision Date May 05, 2025
Days to Decision 222 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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