HGM — System, Monitoring, Perinatal Class II
FDA Device Classification
Classification Details
- Product Code
- HGM
- Device Class
- Class II
- Regulation Number
- 884.2740
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253021 | sibel health | ANNE Maternal | February 26, 2026 |
| K250777 | huntleigh healthcare | Sonicaid Team3 | September 19, 2025 |
| K241882 | edan instruments | Fetal & Maternal Monitor (F15A, F15A Air) | August 27, 2025 |
| K241368 | huntleigh healthcare | Sonicaid Team3 | February 3, 2025 |
| K241009 | perigen | PeriCALM Patterns 3.0 | January 10, 2025 |
| K233440 | philips medizin systeme boeblingen | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) | July 2, 2024 |
| K231964 | datex ohmeda | Novii+ Wireless Patch System | December 8, 2023 |
| K222327 | bloom technologies | Bloomlife MFM-Pro | February 13, 2023 |
| K220732 | ge medical systems information technologies | Mural Perinatal Surveillance | June 23, 2022 |
| K200975 | huntleigh healthcare limited | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | June 24, 2020 |
| K173941 | philips medizin systeme boeblingen | IntelliSpace Perinatal Rev.K.00 | September 10, 2018 |
| K173042 | edan instruments | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: | August 30, 2018 |
| K173715 | alertwatch | AlertWatch:OB | April 23, 2018 |
| K171178 | edan instruments | Central Monitoring System | September 6, 2017 |
| K171865 | farus | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Moni | August 24, 2017 |
| K161902 | mindchild medical | Meridian M110 Fetal Monitoring System | January 12, 2017 |
| K153580 | guangdong biolight meditech co | Central Monitoring System | September 7, 2016 |
| K150398 | ob tools | EUM 100Pro | August 6, 2015 |
| K142799 | bistos co | Model BT-220L and BT-220C | July 9, 2015 |
| K150901 | edan instruments | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | July 1, 2015 |