Intellivue MX40 Patient Monitor
FDA 510(k) K113125 · Philips Medical Systems
510(k) numberK113125
Submission
- Device name
- Intellivue MX40 Patient Monitor
- Applicant
- Philips Medical Systems
Andover, MA, US - Received
- October 24, 2011
- Decision date
- November 17, 2011
- 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
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Questions and answers
When was Intellivue MX40 Patient Monitor cleared by the FDA?
Intellivue MX40 Patient Monitor (K113125) received a 510(k) decision of Substantially Equivalent on November 17, 2011, 24 days after the submission was received.
What is the product code of K113125?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.