Contec Pocket Fetal Doppler
FDA 510(k) K082480 · Contec Medical System Co., Ltd.
510(k) numberK082480
Submission
- Device name
- Contec Pocket Fetal Doppler
- Applicant
- Contec Medical System Co., Ltd.
Zhong Shan, Shanghai, CN - Received
- August 28, 2008
- Decision date
- February 25, 2009
- 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 |
| 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 |
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| K101273 | Dynamic ECG System Model TLC5000MLO · Traditional | 09/30/2011SE |
| K110156 | Ambulatory Bllod Pressure Monitor, Electronic Sphygmomanometer,DXN · Traditional | 07/27/2011SE |
| K101692 | Patient MonitorMHX · Traditional | 06/28/2011SE |
| K110774 | Electronic SphygmomanometerDXN · Traditional | 05/13/2011SE |
| K101127 | Patient Monitor, Model PM50MWI · Traditional | 06/11/2010SE |
| K090936 | Single-Channel Handheld Electrocardiograph, Model ECG80ADPS · Traditional | 08/25/2009SE |
| K090671 | Pulse Oximeter, Models CMS50E, CMS50F, CMS60C, CMS60DDQA · Traditional | 06/11/2009SE |
| K082641 | Fingertip Pulse Oximeter, Models CMS-50D, CMS-50L, CMS-50DLDQA · Special | 11/10/2008SE |
Questions and answers
When was Contec Pocket Fetal Doppler cleared by the FDA?
Contec Pocket Fetal Doppler (K082480) received a 510(k) decision of Substantially Equivalent on February 25, 2009, 181 days after the submission was received.
What is the product code of K082480?
The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.