Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
FDA 510(k) K232893 · Contec Medical Systems Co.,Ltd
510(k) numberK232893
Submission
- Device name
- Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
- Applicant
- Contec Medical Systems Co.,Ltd
Qinhuangdao, CN - Received
- September 18, 2023
- Decision date
- June 14, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNG – Monitor, Ultrasonic, Fetal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2660
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KNG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252669 | Fetal Doppler U8-25, U9-25KNG · Traditional | Zhongshan Xiaolan Town Senlan Electronic Factory | 01/08/2026SE |
| K242846 | Doppler FHR Detector (BF-500D+, BF-560)KNG · Traditional | Shenzhen Bestman Instrument Co., Ltd. | 06/26/2025SE |
| K233823 | Ultrasonic Fetal DopplerKNG · Traditional | Shenzhen Jamr Technology Co., Ltd. | 06/28/2024SE |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNG · Traditional | Contec Medical Systems Co.,Ltd | 09/28/2022SE |
| K211940 | Fetal DopplerKNG · Traditional | Shenzhen Taikang Medical Equipment Co., Ltd. | 01/07/2022SE |
| K212084 | Fetal DopplerKNG · Traditional | Shenzhen Mericonn Technology Co., Ltd. | 11/03/2021SE |
| K191110 | HeraBEAT USKNG · Traditional | Heramed, Ltd. | 11/14/2019SE |
| K182526 | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B…KNG · Traditional | Vcomin Technology Limited | 05/29/2019SE |
| K182710 | Fetal Doppler, Model FD88KNG · Traditional | Shenzzhen Luckcome Technology Inc., Ltd. | 03/01/2019SE |
| K182190 | Fetal DopplerKNG · Traditional | Shenzhen AOJ Medical Technology Co., Ltd. | 12/19/2018SE |
More from Shenzhen AOJ Medical Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K232895 | B-Ultrasound Diagnostic SystemIYO · Traditional | 05/03/2024SE |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound…IYN · Traditional | 05/02/2024SE |
| K220245 | Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)KNG · Traditional | 09/28/2022SE |
| K202757 | CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50…DXN · Traditional | 04/28/2021SE |
| K201980 | Infrared ThermometerFLL · Traditional | 12/18/2020SE |
| K171360 | CONTEC ElectrocardiographDPS · Traditional | 01/22/2018SE |
| K170856 | CMS600P2 B-Ultrasound Diagnostic SystemIYO · Traditional | 11/17/2017SE |
| K170954 | Portable ECG MonitorDPS · Traditional | 05/30/2017SE |
| K152863 | Portable ECG MonitorDPS · Traditional | 06/22/2016SE |
| K141362 | Pulse Oximeter CMS50EWDQA · Traditional | 04/23/2015SE |
Questions and answers
When was Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) cleared by the FDA?
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) (K232893) received a 510(k) decision of Substantially Equivalent on June 14, 2024, 270 days after the submission was received.
What is the product code of K232893?
The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.