The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors, with 802.11 Wireless LAN
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K052961 FDA 510(k)
- FDA Product Code
- DRG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2910 FDA 510(k)
- Regulation Number
- 870.2910 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors, with 802.11 Wireless LAN are physiological signal transmitters and receivers designed for monitoring patient vital signs. These devices are substantially equivalent to previously cleared patient monitors and are classified as Class II medical devices under FDA regulation 870.2910.
The monitors are intended for use in clinical settings and are supplied as reusable devices. They incorporate 802.11 wireless LAN technology for data transmission and are authorized under FDA 510(k) clearance K052961. The device is manufactured by Philips Medical Systems and is subject to cardiovascular specialty classification.
Frequently asked questions
What is the Philips MP20 through MP90 IntelliVue Patient Monitor with 802.11 Wireless LAN used for?
The Philips MP20 through MP90 IntelliVue Patient Monitors with 802.11 Wireless LAN are physiological signal transmitters and receivers designed for monitoring patient vital signs in clinical settings, transmitting data via wireless LAN to support continuous patient surveillance.
Is the Philips MP20 through MP90 IntelliVue Patient Monitor with 802.11 Wireless LAN reusable or single-use?
The device is supplied as a reusable device, meaning it is designed for multiple uses after proper cleaning and disinfection between patients, in accordance with the manufacturer’s instructions for use and infection control protocols.
What wireless technology does the Philips MP20 through MP90 IntelliVue Patient Monitor incorporate?
The device incorporates 802.11 Wireless LAN technology to enable wireless transmission of physiological signals, allowing for flexible patient monitoring without the constraints of wired connections in clinical environments.
What regulatory pathway was used for the Philips MP20 through MP90 IntelliVue Patient Monitor with 802.11 Wireless LAN?
The device was authorized under FDA 510(k) clearance K052961, demonstrating substantial equivalence to previously cleared patient monitors, and is classified as a Class II medical device under FDA regulation 870.2910.
What is the device classification and specialty classification for the Philips MP20 through MP90 IntelliVue Patient Monitor with 802.11 Wireless LAN?
The device is classified as a Class II medical device and is assigned to the cardiovascular specialty, as indicated by the product code DRG and the advisory committee description CV, reflecting its intended use in monitoring cardiovascular and other vital signs.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Philips MP20, MP60, MP40, MP30, MP50 User Manual, IntelliVue MP20, MP20Junior, MP30, MP40, MP50, MP60, MP70, MP80, MP90 ..., Philips IntelliVue MP20/30, MP40/50, MP60/70/80/90 User Manual | Manualzz, Global home | Philips
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K052961 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
Sources (1)
- FDA 510(k) K052961 24 fields · synced Oct 6, 2026