Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90
FDA 510(k) K091927 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
510(k) numberK091927
Submission
- Device name
- Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Boeblingen, Baden-Wuerttemberg, DE - Received
- June 30, 2009
- Decision date
- November 3, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| 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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| K132320 | Intellivue CL Respiration PodBZQ · Traditional | 03/26/2014SE |
| K131872 | Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550MHX · Special | 10/17/2013SE |
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| K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450MHX · Special | 06/14/2013SE |
| K120366 | Intellivue Patient MonitorMHX · Abbreviated | 07/18/2012SE |
| K113441 | Physiological Monitor, Patient MonitorMHX · Traditional | 03/22/2012SE |
| K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…DXJ · Abbreviated | 10/04/2011SE |
| K110474 | Philips Intellivue TCG10LKD · Abbreviated | 09/30/2011SE |
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Questions and answers
When was Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 cleared by the FDA?
Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 (K091927) received a 510(k) decision of Substantially Equivalent on November 3, 2009, 126 days after the submission was received.
What is the product code of K091927?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.