Mar 31, 2025 · 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing ... CLIA | TPLC : New Search: Back To Search Results: …

Oct 10, 2018 · IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for …

Mar 16, 2021 · This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information is …

This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code.

Mar 28, 2019 · The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State . FDA Determined Cause 2

FDA premarket device registration for Intellivue Mx40 Patient Monitor distributed by PHILLIPS MEDICAL SYSTEMS

Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. …

The Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. …

The IntelliVue MX40 patient wearable monitor gives you technology, intelligent design, and innovative features you expect from Philips – in a device light enough and small enough to be …

There are four basic steps to submit a 510 (k) through the program. Determine if your device is eligible. … Class I and Class II devices are eligible); Search the FDA 's Device Classification...