FDA 510(k)

IntelliVue Measurement Rack 6000 (867317)

Numéro K : K253654 · 2026-03-30

DemandeurPhilips Medizin Systeme Böblingen GmbH

Date de décision2026-03-30

Code produitMSX

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

IntelliVue Measurement Rack 6000 (867317) 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 2026-03-30 under 510(k) number K253654. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the IntelliVue Measurement Rack 6000 (867317)?

IntelliVue Measurement Rack 6000 (867317) is a medical device that received FDA 510(k) clearance on 2026-03-30. The listed applicant is Philips Medizin Systeme Böblingen GmbH. The 510(k) number is K253654.

When did IntelliVue Measurement Rack 6000 (867317) receive FDA 510(k) clearance?

IntelliVue Measurement Rack 6000 (867317) received FDA 510(k) clearance on 2026-03-30, under 510(k) number K253654.

Who is the listed applicant for IntelliVue Measurement Rack 6000 (867317)?

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 IntelliVue Measurement Rack 6000 (867317)?

The FDA product code for IntelliVue Measurement Rack 6000 (867317) is MSX.

Essais cliniques associés

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Autres dossiers indiquant Philips Medizin Systeme Böblingen GmbH en tant que demandeur

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)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)K241890Philips Holter Analysis System 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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Source officielle

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