Philips Avalon Fetal / Maternal Monitors Fm20, Fm30, Fm40 And Fm50
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140535 FDA 510(k)
- FDA Product Code
- HGM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2740 FDA 510(k)
- Regulation Number
- 884.2740 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Philips Avalon Fetal/Maternal Monitors (FM20, FM30, FM40, FM50) are classified as Systems, Monitoring, Perinatal, designed for continuous external and optional internal fetal and maternal monitoring during pregnancy and labor. These devices provide real-time assessment of fetal heart rate and maternal vital signs, supporting obstetric care by enabling early detection of fetal distress or complications.
The monitors are intended for use in clinical settings such as labor and delivery units, operating rooms, and postpartum wards. Supplied as reusable medical devices, they comply with FDA 510(k) clearance and MDD (Medical Device Directive) requirements. Models vary in functionality, with the FM20 offering external monitoring, while the FM30 and FM50 include internal fetal monitoring capabilities. Storage and maintenance follow manufacturer guidelines to ensure device reliability and sterility where applicable.
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 - Avalon FM20 Fetal monitor - Philips, Avalon Fetal Monitors - Philips, Philips Avalon Fetal Monitor FM20/FM30/FM40/FM50 ... - Manuals+, Avalon Fetal Monitors - Philips
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K140535 | Class II | Active |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- FDA Applicant
- Philips Medizin Systeme Boblingen GmbH
Sources (2)
- FDA 510(k) K140535 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026