Philips Avalon Fetal Monitor
FDA 510(k) K102958 · Philips Medizin Systeme Boblingen GmbH
510(k) numberK102958
Submission
- Device name
- Philips Avalon Fetal Monitor
- Applicant
- Philips Medizin Systeme Boblingen GmbH
Boeblingen, DE - Received
- October 4, 2010
- Decision date
- March 18, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HGM – System, Monitoring, Perinatal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2740
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254036 | Novii+ Wireless Patch SystemHGM · Traditional | Datex Ohmeda, Inc. | 08/10/2026SE |
| K253021 | ANNE MaternalHGM · Traditional | Sibel Health, Inc. | 02/26/2026SE |
| K250777 | Sonicaid Team3HGM · Traditional | Huntleigh Healthcare , Ltd. | 09/19/2025SE |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air)HGM · Traditional | Edan Instruments, Inc. | 08/27/2025SE |
| K241368 | Sonicaid Team3HGM · Traditional | Huntleigh Healthcare , Ltd. | 02/03/2025SE |
| K241009 | PeriCALM Patterns 3.0HGM · Traditional | Perigen, Inc. | 01/10/2025SE |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…HGM · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/02/2024SE |
| K231964 | Novii+ Wireless Patch SystemHGM · Traditional | Datex Ohmeda | 12/08/2023SE |
| K222327 | Bloomlife MFM-ProHGM · Traditional | Bloom Technologies NV | 02/13/2023SE |
| K220732 | Mural Perinatal SurveillanceHGM · Traditional | Ge Medical Systems Information Technologies, Inc. | 06/23/2022SE |
More from Ge Medical Systems Information Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K151736 | Philips IntelliVue GuardianSoftwareDXJ · Special | 10/21/2015SE |
| K140535 | Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50HGM · Abbreviated | 11/25/2014SE |
| K113657 | Intellivue Patient MonitorMHX · Traditional | 03/22/2012SE |
| K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…MHX · Special | 10/21/2010SE |
| K090360 | Philips M3001A Multi Measurement ServerDQA · Special | 05/04/2009SE |
| K083228 | Philips Intellivue MP5 Patient MonitorMHX · Special | 11/24/2008SE |
| K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsMHX · Special | 03/24/2006SE |
| K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsMSX · Special | 11/12/2004SE |
| K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,AND MP90 Patient Monitors, Release B.O.DSI · Special | 10/10/2003SE |
| K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release A.20MHX · Special | 05/29/2003SE |
Questions and answers
When was Philips Avalon Fetal Monitor cleared by the FDA?
Philips Avalon Fetal Monitor (K102958) received a 510(k) decision of Substantially Equivalent on March 18, 2011, 165 days after the submission was received.
What is the product code of K102958?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.