M3290B Philips IntelliVue Information Center iX
FDA 510(k) K143057 · Philips Medical Systems
510(k) numberK143057
Submission
- Device name
- M3290B Philips IntelliVue Information Center iX
- Applicant
- Philips Medical Systems
Andover, MA, US - Received
- October 24, 2014
- Decision date
- December 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code MSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261287 | Digistat CareMSX · Traditional | Ascom Ums Srl Unipersonale | 09/12/2026SE |
| K260211 | Dashboard (P007000)MSX · Traditional | Hill-Rom, Inc. | 08/13/2026SE |
| K261367 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 07/26/2026SE |
| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/30/2026SE |
| 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 |
More from Draeger Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemIYN · Traditional | 09/24/2021SE |
| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | 09/08/2021SE |
| K210560 | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50…DPS · Special | 06/30/2021SE |
| K191738 | PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph…DPS · Traditional | 09/29/2020SE |
| K192875 | Philips Biosensor BX100DRG · Traditional | 04/16/2020SE |
| K183387 | M3290B Patient Information Center iXMHX · Traditional | 08/06/2019SE |
| K180017 | MX40 Release C.01MHX · Special | 07/24/2018SE |
| K172226 | MX40 Release B.07MHX · Traditional | 11/09/2017SE |
| K163584 | M3290B Philips IntelliVue Information Center iXMHX · Traditional | 07/07/2017SE |
| K163649 | SureSigns VS3; SureSigns VS4DSJ · Special | 03/31/2017SE |
Questions and answers
When was M3290B Philips IntelliVue Information Center iX cleared by the FDA?
M3290B Philips IntelliVue Information Center iX (K143057) received a 510(k) decision of Substantially Equivalent on December 3, 2014, 40 days after the submission was received.
What is the product code of K143057?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.