Mini Telemetry System
FDA 510(k) K110556 · Wipro GE Healthcare Private, Ltd.
510(k) numberK110556
Submission
- Device name
- Mini Telemetry System
- Applicant
- Wipro GE Healthcare Private, Ltd.
Laurel, MD, US - Received
- February 28, 2011
- Decision date
- July 19, 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 |
|---|---|---|
| K123681 | 1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex CoilMOS · Traditional | 02/22/2013SE |
| K121625 | Lullaby TM WarmerFMT · Traditional | 09/14/2012SE |
| K120168 | Lullaby LED Phottherapy SystemLBI · Traditional | 05/02/2012SE |
| K102104 | GE Vivid P3 Diagnostic Ultrasound Imaging SystemIYN · Special | 10/01/2010SE |
Questions and answers
When was Mini Telemetry System cleared by the FDA?
Mini Telemetry System (K110556) received a 510(k) decision of Substantially Equivalent on July 19, 2011, 141 days after the submission was received.
What is the product code of K110556?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.