Model IM77 Intrapartum Fetal Monitor (Modification)
FDA 510(k) K955931 · Advanced Medical Systems, Inc.
510(k) numberK955931
Submission
- Device name
- Model IM77 Intrapartum Fetal Monitor (Modification)
- Applicant
- Advanced Medical Systems, Inc.
Hamden, CT, US - Received
- December 15, 1995
- Decision date
- August 14, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K952031 | Ultrasound Transducer, Model US917HGL · Traditional | 07/18/1995SE |
| K940898 | Model IM77 Intrapartum Fetal MonitorHGM · Traditional | 03/01/1995SE |
| K923335 | Ultrasound Transucer, Model US915 -- ModificationHGL · Traditional | 07/22/1994SE |
| K932278 | PFM Professional 7000 SpirometerBTY · Traditional | 12/17/1993SE |
| K911657 | Fetal Scalp Spiral ElectrodeHGP · Traditional | 07/11/1991SE |
| K902190 | Fetal Pulse Detector Model DOP-1HEK · Traditional | 10/22/1990SE |
| K894568 | New RAD-8 Treatment Planning Computer SystemKPQ · Traditional | 01/09/1990SE |
| K891672 | Pul-Tron 100K Professional SpirometerBZG · Traditional | 06/16/1989SE |
| K880756 | Model PM-20A Physiological MonitorDQA · Traditional | 09/27/1988SE |
Questions and answers
When was Model IM77 Intrapartum Fetal Monitor (Modification) cleared by the FDA?
Model IM77 Intrapartum Fetal Monitor (Modification) (K955931) received a 510(k) decision of Substantially Equivalent on August 14, 1996, 243 days after the submission was received.
What is the product code of K955931?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.