HGM — System, Monitoring, Perinatal Class II
FDA product code HGM covers "System, Monitoring, Perinatal", a Class II medical device regulated under 21 CFR 884.2740. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K254036 | Datex Ohmeda | Novii+ Wireless Patch System | Aug 10, 2026 |
| K253021 | Sibel Health | ANNE Maternal | Feb 26, 2026 |
| K250777 | Huntleigh Healthcare | Sonicaid Team3 | Sep 19, 2025 |
| K241882 | Edan Instruments | Fetal & Maternal Monitor (F15A, F15A Air) | Aug 27, 2025 |
| K241368 | Huntleigh Healthcare | Sonicaid Team3 | Feb 3, 2025 |
| K241009 | Perigen | PeriCALM Patterns 3.0 | Jan 10, 2025 |
| K233440 | Philips Medizin Systeme Boeblingen | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) | Jul 2, 2024 |
| K231964 | Datex Ohmeda | Novii+ Wireless Patch System | Dec 8, 2023 |
| K222327 | Bloom Technologies | Bloomlife MFM-Pro | Feb 13, 2023 |
| K220732 | Ge Medical Systems Information Technologies | Mural Perinatal Surveillance | Jun 23, 2022 |
| K200975 | Huntleigh Healthcare Limited | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Jun 24, 2020 |
| K173941 | Philips Medizin Systeme Boeblingen | IntelliSpace Perinatal Rev.K.00 | Sep 10, 2018 |
| K173042 | Edan Instruments | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: | Aug 30, 2018 |
| K173715 | Alertwatch | AlertWatch:OB | Apr 23, 2018 |
| K171178 | Edan Instruments | Central Monitoring System | Sep 6, 2017 |
| K171865 | Farus | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Moni | Aug 24, 2017 |
| K161902 | Mindchild Medical | Meridian M110 Fetal Monitoring System | Jan 12, 2017 |
| K153580 | Guangdong Biolight Meditech Co | Central Monitoring System | Sep 7, 2016 |
| K150398 | Ob Tools | EUM 100Pro | Aug 6, 2015 |
| K142799 | Bistos Co | Model BT-220L and BT-220C | Jul 9, 2015 |