Fetal Doppler
FDA 510(k) K212084 · Shenzhen Mericonn Technology Co., Ltd.
510(k) numberK212084
Submission
- Device name
- Fetal Doppler
- Applicant
- Shenzhen Mericonn Technology Co., Ltd.
Shenzhen, CN - Received
- July 2, 2021
- Decision date
- November 3, 2021
- 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 |
| K232893 | Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal…KNG · Traditional | Contec Medical Systems Co.,Ltd | 06/14/2024SE |
| 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 |
| 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 |
|---|---|---|
| K212300 | Pulse OximeterDQA · Traditional | 02/25/2022SE |
Questions and answers
When was Fetal Doppler cleared by the FDA?
Fetal Doppler (K212084) received a 510(k) decision of Substantially Equivalent on November 3, 2021, 124 days after the submission was received.
What is the product code of K212084?
The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.