Philips Telemedicine Server/System, Model 861441
FDA 510(k) K091176 · Philips Medical Systems
510(k) numberK091176
Submission
- Device name
- Philips Telemedicine Server/System, Model 861441
- Applicant
- Philips Medical Systems
Andover, MA, US - Received
- April 22, 2009
- Decision date
- November 13, 2009
- 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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| 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 |
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| 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 |
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Questions and answers
When was Philips Telemedicine Server/System, Model 861441 cleared by the FDA?
Philips Telemedicine Server/System, Model 861441 (K091176) received a 510(k) decision of Substantially Equivalent on November 13, 2009, 205 days after the submission was received.
What is the product code of K091176?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.