FDA 510(k)

Philips Holter Analysis System

Número K: K241890 · 2025-03-21

RequerentePhilips Medizin Systeme Böblingen GmbH

Data da decisão2025-03-21

Código do produtoMLO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Philips Holter Analysis System 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 2025-03-21 under 510(k) number K241890. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Philips Holter Analysis System?

Philips Holter Analysis System is a medical device that received FDA 510(k) clearance on 2025-03-21. The listed applicant is Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K241890.

When did Philips Holter Analysis System receive FDA 510(k) clearance?

Philips Holter Analysis System received FDA 510(k) clearance on 2025-03-21, under 510(k) number K241890.

Who is the listed applicant for Philips Holter Analysis System?

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 Philips Holter Analysis System?

The FDA product code for Philips Holter Analysis System is MLO.

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Outros registros que listam Philips Medizin Systeme Böblingen GmbH como candidato(a)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)K253654IntelliVue Measurement Rack 6000 (867317)K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)K242962Telemetry Monitor 5500 Release 4.0 (867232)K243545Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn

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