The Philips Intellivue MP40, MP50, MP60, MP70,AND MP90 Patient Monitors, Release B.O.
FDA 510(k) K032858 · Philips Medizin Systeme Boblingen GmbH
510(k) numberK032858
Submission
- Device name
- The Philips Intellivue MP40, MP50, MP60, MP70,AND MP90 Patient Monitors, Release B.O.
- Applicant
- Philips Medizin Systeme Boblingen GmbH
Boeblingen, DE - Received
- September 12, 2003
- Decision date
- October 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code DSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0)DSI · Traditional | Boston Scientific Cardiac Diagnostic… | 01/23/2026SE |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
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| K113657 | Intellivue Patient MonitorMHX · Traditional | 03/22/2012SE |
| K102958 | Philips Avalon Fetal MonitorHGM · Traditional | 03/18/2011SE |
| K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…MHX · Special | 10/21/2010SE |
| K090360 | Philips M3001A Multi Measurement ServerDQA · Special | 05/04/2009SE |
| K083228 | Philips Intellivue MP5 Patient MonitorMHX · Special | 11/24/2008SE |
| K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsMHX · Special | 03/24/2006SE |
| K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsMSX · Special | 11/12/2004SE |
| K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release A.20MHX · Special | 05/29/2003SE |
Questions and answers
When was The Philips Intellivue MP40, MP50, MP60, MP70,AND MP90 Patient Monitors, Release B.O. cleared by the FDA?
The Philips Intellivue MP40, MP50, MP60, MP70,AND MP90 Patient Monitors, Release B.O. (K032858) received a 510(k) decision of Substantially Equivalent on October 10, 2003, 28 days after the submission was received.
What is the product code of K032858?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.