Central Monitoring System
FDA 510(k) K153580 · Guangdong Biolight Meditech Co., Ltd.
510(k) numberK153580
Submission
- Device name
- Central Monitoring System
- Applicant
- Guangdong Biolight Meditech Co., Ltd.
Zhuhai, CN - Received
- December 15, 2015
- Decision date
- September 7, 2016
- 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 |
|---|---|---|
| K181919 | Patient MonitorMWI · Traditional | 04/05/2019SE |
| K170514 | Central Monitoring SystemMHX · Traditional | 05/24/2017SE |
| K162234 | Truscope Ultra Patient MonitorMWI · Special | 01/04/2017SE |
| K160349 | Electronic SphygmomanometerDXN · Traditional | 11/03/2016SE |
| K153135 | Vital Signs MonitorMWI · Special | 02/25/2016SE |
| K152739 | Electronic ThermometerFLL · Traditional | 02/09/2016SE |
| K151287 | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70DDQA · Traditional | 01/06/2016SE |
| K131858 | Digital ElectrocardiographDPS · Traditional | 06/11/2014SE |
| K131762 | Handheld MonitorMWI · Traditional | 06/06/2014SE |
| K131941 | Fetal MonitorsHGM · Traditional | 05/15/2014SE |
Questions and answers
When was Central Monitoring System cleared by the FDA?
Central Monitoring System (K153580) received a 510(k) decision of Substantially Equivalent on September 7, 2016, 267 days after the submission was received.
What is the product code of K153580?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.