Sonicaid FM820 and FM830 Encore
FDA 510(k) K090285 · Huntleigh Healthcare , Ltd.
510(k) numberK090285
Submission
- Device name
- Sonicaid FM820 and FM830 Encore
- Applicant
- Huntleigh Healthcare , Ltd.
Cardiff, GB - Received
- February 5, 2009
- Decision date
- July 15, 2009
- 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 |
|---|---|---|
| K250777 | Sonicaid Team3HGM · Traditional | 09/19/2025SE |
| K241368 | Sonicaid Team3HGM · Traditional | 02/03/2025SE |
| K211200 | WoundExpressJOW · Traditional | 09/03/2021SE |
| K201425 | Disposable Intraoperative Probe (DIOP8)ITX · Traditional | 02/19/2021SE |
| K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHGM · Traditional | 06/24/2020SE |
| K183574 | SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular ProbesDPW · Abbreviated | 09/06/2019SE |
| K152228 | Hydroven 12, Hydroven 12 GarmentsJOW · Traditional | 04/04/2016SE |
| K132650 | Sonicaid Freedom Wireless Fetal Monitoring SystemHGM · Traditional | 02/07/2014SE |
| K121108 | Dopplex AbilityJOM · Traditional | 01/03/2013SE |
| K081572 | Smartsigns MinpulseDQA · Traditional | 10/01/2008SE |
Questions and answers
When was Sonicaid FM820 and FM830 Encore cleared by the FDA?
Sonicaid FM820 and FM830 Encore (K090285) received a 510(k) decision of Substantially Equivalent on July 15, 2009, 160 days after the submission was received.
What is the product code of K090285?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.