FM-9000 Plus Fetal and Maternal Monitor
FDA 510(k) K112317 · Advanced Instrumentations, Inc.
510(k) numberK112317
Submission
- Device name
- FM-9000 Plus Fetal and Maternal Monitor
- Applicant
- Advanced Instrumentations, Inc.
Hialeah, FL, US - Received
- August 11, 2011
- Decision date
- December 21, 2011
- 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 |
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| K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemIYO · Abbreviated | 12/01/2017SE |
| K172055 | DUS-7000 Digital Color Doppler Ultrasound SystemIYN · Abbreviated | 08/31/2017SE |
| K141194 | FM-3000 Fetal MonitorHGM · Traditional | 11/19/2014SE |
| K132077 | Patient MonitorMHX · Traditional | 04/23/2014SE |
| K132059 | Diagnostic Ultrasound SystemIYN · Traditional | 10/25/2013SE |
| K123048 | Patient Monitor Models PM-2000A, PM-2000A+, PM-2000A ProMHX · Traditional | 01/11/2013SE |
| K120075 | AM-6000 Anesthesia MachineBSZ · Traditional | 01/26/2012SE |
| K112529 | TD-5000 & TD-6000 Ultrasonic Tabletop DopplerKNG · Traditional | 10/27/2011SE |
| K112022 | DUS-3000/DUS-3000PLUS Digital Ultrasonic Diagnostic Imaging SystemIYO · Traditional | 09/22/2011SE |
| K111934 | PD-100 Series Ultrasonic Pocket DopplerKNG · Traditional | 09/22/2011SE |
Questions and answers
When was FM-9000 Plus Fetal and Maternal Monitor cleared by the FDA?
FM-9000 Plus Fetal and Maternal Monitor (K112317) received a 510(k) decision of Substantially Equivalent on December 21, 2011, 132 days after the submission was received.
What is the product code of K112317?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.