FDA 510(k)

Telemetry Monitor 5500 Release 4.0 (867232)

K-Nummer: K242962 · 2025-05-05

AntragstellerPhilips Medizin Systeme Böblingen GmbH

Entscheidungsdatum2025-05-05

ProduktcodeMHX

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

Telemetry Monitor 5500 Release 4.0 (867232) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Böblingen GmbH. It received FDA 510(k) clearance on 2025-05-05 under 510(k) number K242962. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Telemetry Monitor 5500 Release 4.0 (867232)?

Telemetry Monitor 5500 Release 4.0 (867232) is a medical device that received FDA 510(k) clearance on 2025-05-05. The listed applicant is Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K242962.

When did Telemetry Monitor 5500 Release 4.0 (867232) receive FDA 510(k) clearance?

Telemetry Monitor 5500 Release 4.0 (867232) received FDA 510(k) clearance on 2025-05-05, under 510(k) number K242962.

Who is the listed applicant for Telemetry Monitor 5500 Release 4.0 (867232)?

The FDA 510(k) record lists Philips Medizin Systeme Böblingen GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Telemetry Monitor 5500 Release 4.0 (867232)?

The FDA product code for Telemetry Monitor 5500 Release 4.0 (867232) is MHX.

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