FC 1400 Fetal Monitor
FDA 510(k) K043598 · Bionet Co., Ltd.
510(k) numberK043598
Submission
- Device name
- FC 1400 Fetal Monitor
- Applicant
- Bionet Co., Ltd.
Wonju, Kwangwon-Do, KR - Received
- December 29, 2004
- Decision date
- December 16, 2005
- 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
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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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| K082008 | Bionet BM3PLUS Patient MonitorMWI · Traditional | 12/11/2008SE |
| K043597 | FC 700 Fetal MonitorHGM · Traditional | 12/16/2005SE |
Questions and answers
When was FC 1400 Fetal Monitor cleared by the FDA?
FC 1400 Fetal Monitor (K043598) received a 510(k) decision of Substantially Equivalent on December 16, 2005, 352 days after the submission was received.
What is the product code of K043598?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.