Model BT-220L and BT-220C
FDA 510(k) K142799 · Bistos Co., Ltd.
510(k) numberK142799
Submission
- Device name
- Model BT-220L and BT-220C
- Applicant
- Bistos Co., Ltd.
Ramsey, NJ, US - Received
- September 29, 2014
- Decision date
- July 9, 2015
- 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
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| 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.
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|---|---|---|
| K251512 | Hi bebe super (BT-150B)HGX · Special | 09/25/2025SE |
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| K210289 | Infant Phototherapy EquipmentLBI · Traditional | 05/28/2021SE |
| K200675 | Hi bebe super (Models BT-150S and BT-150L)HGX · Special | 02/10/2021SE |
| K160274 | Hi bebe plusHGX · Traditional | 09/01/2016SE |
| K132543 | Infant IncubatorFMZ · Traditional | 07/03/2014SE |
| K121267 | BT-200V Vascular DopplerHGM · Traditional | 08/02/2012SE |
| K103545 | BT-350HGM · Traditional | 05/13/2011SE |
| K100885 | Fetal Monitor Model: BT-200THGM · Traditional | 06/07/2010SE |
| K052190 | Fetal Monitor, Models BT-300 and BT-200HGM · Traditional | 10/04/2005SE |
Questions and answers
When was Model BT-220L and BT-220C cleared by the FDA?
Model BT-220L and BT-220C (K142799) received a 510(k) decision of Substantially Equivalent on July 9, 2015, 283 days after the submission was received.
What is the product code of K142799?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.