Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50
FDA 510(k) K111083 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
510(k) numberK111083
Submission
- Device name
- Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Boeblingen, Baden-Wuerttemberg, DE - Received
- April 19, 2011
- Decision date
- August 17, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
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|---|---|---|---|
| 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 |
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| K132320 | Intellivue CL Respiration PodBZQ · Traditional | 03/26/2014SE |
| K131872 | Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550MHX · Special | 10/17/2013SE |
| K131829 | Intellivue Patient MonitorMHX · Special | 08/16/2013SE |
| K130849 | Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450MHX · Special | 06/14/2013SE |
| K120366 | Intellivue Patient MonitorMHX · Abbreviated | 07/18/2012SE |
| K113441 | Physiological Monitor, Patient MonitorMHX · Traditional | 03/22/2012SE |
| K111905 | Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215…DXJ · Abbreviated | 10/04/2011SE |
| K110474 | Philips Intellivue TCG10LKD · Abbreviated | 09/30/2011SE |
| K110622 | Intellivue Patient MonitorMHX · Special | 03/31/2011SE |
Questions and answers
When was Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 cleared by the FDA?
Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50 (K111083) received a 510(k) decision of Substantially Equivalent on August 17, 2011, 120 days after the submission was received.
What is the product code of K111083?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.