Model PC-860 Fetal Doppler
FDA 510(k) K082055 · Shenzhen Creative Industry Co., Ltd.
510(k) numberK082055
Submission
- Device name
- Model PC-860 Fetal Doppler
- Applicant
- Shenzhen Creative Industry Co., Ltd.
Chenzhen City, CN - Received
- July 21, 2008
- Decision date
- February 6, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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| K201468 | Pulse OximeterDQA · Traditional | 01/25/2021SE |
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| K172792 | Handheld Pulse Oximeter, Model SP-20DQA · Traditional | 11/13/2018SE |
| K170047 | All-in-One Health Monitor, PC-303MWI · Traditional | 09/09/2017SE |
| K150093 | Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E…DQA · Special | 06/03/2015SE |
| K123711 | Patient MonitorMWI · Traditional | 10/01/2013SE |
| K120502 | PC-60NW Fingertip OximeterDQA · Abbreviated | 12/07/2012SE |
| K093016 | Vital Signs MonitorDQA · Traditional | 03/30/2010SE |
| K073152 | PC-180 / Prince 180 Easy ECG MonitorDSH · Traditional | 01/10/2008SE |
| K063641 | PC-60, Non-Invasivepulse OximeterDQA · Traditional | 07/13/2007SE |
Questions and answers
When was Model PC-860 Fetal Doppler cleared by the FDA?
Model PC-860 Fetal Doppler (K082055) received a 510(k) decision of Substantially Equivalent on February 6, 2009, 200 days after the submission was received.
What is the product code of K082055?
The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.