Product code HGM
- Device name
- System, Monitoring, Perinatal
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.2740
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring | Farus, LLC | 2017-08-24 |
| K161902 | Meridian M110 Fetal Monitoring System | Mindchild Medical | 2017-01-12 |
| K153580 | Central Monitoring System | Guangdong Biolight Meditech Co., Ltd. | 2016-09-07 |
| K150398 | EUM 100Pro | Ob Tools, Ltd. | 2015-08-06 |
| K142799 | Model BT-220L and BT-220C | Bistos Co., Ltd. | 2015-07-09 |
| K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express | Edan Instruments, Inc. | 2015-07-01 |
| K142883 | MindChild Meridian M100 Fetal Heart Rate Monitor | Mindchild Medical | 2015-04-17 |
| K143695 | CENTRAL MONITORING SYSTEM | Edan Instruments, Inc. | 2015-03-30 |
| K140535 | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 | Philips Medizin Systeme Boblingen GmbH | 2014-11-25 |
| K141194 | FM-3000 FETAL MONITOR | Advanced Instrumentations, Inc. | 2014-11-19 |
| K131941 | FETAL MONITORS | Guangdong Biolight Meditech Co., Ltd. | 2014-05-15 |
| K132650 | SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM | Huntleigh Healthcare Limited | 2014-02-07 |
| K132918 | SENSE-4BABY SYSTEM | Sense4baby , Inc. | 2013-11-22 |
| K123335 | SUNRAY FETAL MONITOR | Sunray Medical Apparatus Co., Ltd. | 2013-03-21 |
| K121758 | CERNER FETALINK+(VERSION1.0) | Cerner Corp. | 2012-10-09 |
| K120018 | MINDCHILD MERIDIAN FETAL HEART RATE MONITOR | Mindchild Medical | 2012-09-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B153300010 | AirStrip ONE Platform | Airstrip Technologies, Inc. | 2026-03-18 |
| B153301010 | AirStrip ONE Client iOS | Airstrip Technologies, Inc. | 2026-03-18 |
| B153301020 | AirStrip ONE Client Android | Airstrip Technologies, Inc. | 2026-03-18 |
| 00198953043271 | CareIntellect Perinatal | Ge Medical Systems Information Technologies, Inc. | 2025-11-21 |
| 00810149098130 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-10-15 |
| 00810149098123 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-10-15 |
| 00810149098109 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-10-15 |
| 00810149098093 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-10-15 |
| 00810149098055 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-10-14 |
| 00810149098086 | R&D Batteries, Inc. | R & D Batteries, Inc. | 2025-10-14 |
| 20884838116553 | Fetal Measurements | Philips Medizin Systeme Böblingen GmbH | 2025-03-05 |
| 20884838116508 | Fetal Measurements | Philips Medizin Systeme Böblingen GmbH | 2025-01-24 |
| 00860003483541 | PeriWatch Surveillance | PERIGEN INC. | 2023-07-13 |
| 00860003483534 | PeriWatch Surveillance | PERIGEN INC. | 2023-01-03 |
| 08809276943606 | FC1400 | Bionet CO,LTD | 2021-07-15 |
| 08809276943590 | FC700 | Bionet CO,LTD | 2021-07-15 |
| 00884838093218 | Avalon Toco MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838068179 | Avalon CL Fetal & Maternal Pod | Philips Medizin Systeme Böblingen GmbH | 2020-05-22 |
| B510FM30001 | ADVANCED FETAL MONITOR | ADVANCED INSTRUMENTATIONS, INC. | 2020-04-16 |
| B15320020 | AirStrip ONE | Airstrip Technologies, Inc. | 2017-10-09 |
| 00867696000307 | Meridian M110 Fetal Monitoring System | MINDCHILD MEDICAL | 2017-06-06 |
| 00867696000321 | Meridian Disposable fECG Electrode Patch | MINDCHILD MEDICAL | 2017-06-06 |
| M745FM10834 | AIV | AMERICAN IV PRODUCTS, INC. | 2016-09-24 |
| M745FM10833 | AIV | AMERICAN IV PRODUCTS, INC. | 2016-09-24 |
| 00815871020299 | Compact II | Avante | 2016-09-23 |
| 00887529000014 | Hi-dop | Bistos Co., Ltd. | 2016-06-14 |
| 00887529000045 | N/A | Bistos Co., Ltd. | 2016-06-14 |
| 00887529000021 | Hi-bebe | Bistos Co., Ltd. | 2016-06-03 |
| 00887529000052 | N/A | Bistos Co., Ltd. | 2016-06-03 |
| 00887529000038 | Hi-bebe | Bistos Co., Ltd. | 2016-06-01 |