Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
FDA 510(k) clearance K220245 · decided 2022-09-28
Clearance details
- K-number
- K220245
- Device name
- Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
- Applicant
- Contec Medical Systems Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2022-01-28
- Decision date
- 2022-09-28
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- KNG
- Device class
- 2
- Regulation number
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Qinhuangdao, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Contec Medical Systems Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Fetal Doppler U8-25, U9-25 (K252669) | Zhongshan Xiaolan Town Senlan Electronic Factory | 2026-01-08 |
| Doppler FHR Detector (BF-500D+, BF-560) (K242846) | Shenzhen Bestman Instrument Co., Ltd. | 2025-06-26 |
| Ultrasonic Fetal Doppler (K233823) | Shenzhen Jamr Technology Co., Ltd. | 2024-06-28 |
| Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) (K232893) | Contec Medical Systems Co.,Ltd | 2024-06-14 |
| Fetal Doppler (K211940) | Shenzhen Taikang Medical Equipment Co., Ltd. | 2022-01-07 |
| Fetal Doppler (K212084) | Shenzhen Mericonn Technology Co., Ltd. | 2021-11-03 |
| HeraBEATâ„¢ US (K191110) | Heramed, Ltd. | 2019-11-14 |
| Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) (K182526) | Vcomin Technology Limited | 2019-05-29 |
| Fetal Doppler, Model FD88 (K182710) | Shenzzhen Luckcome Technology Inc., Ltd. | 2019-03-01 |
| Fetal Doppler (K182190) | Shenzhen AOJ Medical Technology Co., Ltd. | 2018-12-19 |
| Ultrasonic Doppler (Model YM-2T8) (K180419) | Shenzhen Imdk Medical Technology Co., Ltd. | 2018-07-19 |
| SD1 Ultrasonic Pocket Doppler (K172780) | Edan Instruments, Inc. | 2018-06-06 |
Recalls involving this device
No recalls on record reference this clearance.