IntelliVue Measurement Rack 6000 (867317)
FDA 510(k) K253654 · Philips Medizin Systeme Böblingen GmbH
510(k) numberK253654
Submission
- Device name
- IntelliVue Measurement Rack 6000 (867317)
- Applicant
- Philips Medizin Systeme Böblingen GmbH
Boeblingen, DE - Received
- November 20, 2025
- Decision date
- March 30, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K261367 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 07/26/2026SE |
| K243270 | TigerConnect Alarm ManagementMSX · Traditional | Tigerconnect | 09/30/2025SE |
| K242728 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/31/2025SE |
| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
| K242842 | ANNE View, Central HubMSX · Traditional | Sibel Health, Inc. | 01/08/2025SE |
| K241397 | HinscopeMSX · Traditional | Hinlab Sas | 11/14/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | Draeger Medical Systems, Inc. | 07/12/2024SE |
| K233418 | Biofourmis Everion+ (G2)MSX · Traditional | Biofourmis Singapore Pte., Ltd. | 05/09/2024SE |
More from Biofourmis Singapore Pte., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252821 | Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional | 05/29/2026SE |
| K251702 | IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot…MHX · Traditional | 11/10/2025SE |
| K250453 | IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300)…MHX · Traditional | 09/02/2025SE |
| K242962 | Telemetry Monitor 5500 Release 4.0 (867232)MHX · Traditional | 05/05/2025SE |
| K241890 | Philips Holter Analysis SystemMLO · Traditional | 03/21/2025SE |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…DSA · Traditional | 01/17/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | 12/17/2024SE |
| K221348 | IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)MHX · Traditional | 02/03/2023SE |
| K211900 | Patient Information Center iXMHX · Traditional | 03/04/2022SE |
Questions and answers
When was IntelliVue Measurement Rack 6000 (867317) cleared by the FDA?
IntelliVue Measurement Rack 6000 (867317) (K253654) received a 510(k) decision of Substantially Equivalent on March 30, 2026, 130 days after the submission was received.
What is the product code of K253654?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.