Echo Sounder, ES-102EX
FDA 510(k) K023143 · Koven Technology, Inc.
510(k) numberK023143
Submission
- Device name
- Echo Sounder, ES-102EX
- Applicant
- Koven Technology, Inc.
Houston, TX, US - Received
- September 20, 2002
- Decision date
- December 19, 2002
- 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
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| K212084 | Fetal DopplerKNG · Traditional | Shenzhen Mericonn Technology Co., Ltd. | 11/03/2021SE |
| K191110 | HeraBEAT USKNG · Traditional | Heramed, Ltd. | 11/14/2019SE |
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| K182710 | Fetal Doppler, Model FD88KNG · Traditional | Shenzzhen Luckcome Technology Inc., Ltd. | 03/01/2019SE |
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|---|---|---|
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| K143332 | Fast Sphyg by KovenDXQ · Traditional | 04/14/2015SE |
| K131623 | Smartdop XTJOP · Traditional | 01/17/2014SE |
| K080178 | Valvulotome by KovenMGZ · Traditional | 07/28/2008SE |
| K050601 | Smartdop 45 Vascular DopplerDPW · Traditional | 04/15/2005SE |
| K031931 | Echo Sounder EX-101EX 8 MHZDPW · Traditional | 02/13/2004SE |
| K031504 | Echo Sounder, Single-Handed, Model ES-101EXKNG · Traditional | 07/18/2003SE |
| K010452 | Bi-Directional Doppler Volume Flowmeter, Model DVM-4300 & 4300TDPW · Traditional | 02/12/2002SE |
| K982986 | Tubing Blood Flow Meter Model Number HD-800DPW · Traditional | 11/24/1998SE |
Questions and answers
When was Echo Sounder, ES-102EX cleared by the FDA?
Echo Sounder, ES-102EX (K023143) received a 510(k) decision of Substantially Equivalent on December 19, 2002, 90 days after the submission was received.
What is the product code of K023143?
The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.