510(k) K791038
- Device
- FETASONDE UTERINE ACTIVITY MONITOR
- Applicant
- ROCHE MEDICAL ELECTRONICS, INC.
- 510(k) number
- K791038
- Product code
- HGM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-09-04
- Date received
- 1979-06-05
- Regulation
- 884.2740
- Classification name
- System, Monitoring, Perinatal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code HGM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254036 | Novii+ Wireless Patch System | Datex Ohmeda, Inc. | 2026-08-10 |
| K253021 | ANNE Maternal | Sibel Health, Inc. | 2026-02-26 |
| K250777 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | 2025-09-19 |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air) | Edan Instruments, Inc. | 2025-08-27 |
| K241368 | Sonicaid Team3 | Huntleigh Healthcare , Ltd. | 2025-02-03 |
| K241009 | PeriCALM Patterns 3.0 | Perigen, Inc. | 2025-01-10 |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | Philips Medizin Systeme Boeblingen GmbH | 2024-07-02 |
| K231964 | Novii+ Wireless Patch System | Datex Ohmeda | 2023-12-08 |
| K222327 | Bloomlife MFM-Pro | Bloom Technologies NV | 2023-02-13 |
| K220732 | Mural Perinatal Surveillance | Ge Medical Systems Information Technologies, Inc. | 2022-06-23 |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum | Huntleigh Healthcare Limited | 2020-06-24 |
| K173941 | IntelliSpace Perinatal Rev.K.00 | Philips Medizin Systeme Boeblingen GmbH | 2018-09-10 |
| K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 | Edan Instruments, Inc. | 2018-08-30 |
| K173715 | AlertWatch:OB | Alertwatch, Inc. | 2018-04-23 |
| K171178 | Central Monitoring System | Edan Instruments, Inc. | 2017-09-06 |
Legacy Summary#
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FDA Review#
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