MGD-3
FDA 510(k) K800095 · Kt Medical, Inc.
510(k) numberK800095
Submission
- Device name
- MGD-3
- Applicant
- Kt Medical, Inc.
Mchenry, IL, US - Received
- January 14, 1980
- Decision date
- February 11, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Shenzzhen Luckcome Technology Inc., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K800653 | Sinvision Linear Array Real TimeDXK · Traditional | 07/21/1980SE |
| K800652 | Model E03 Echo-OpthalmoscopeIYO · Traditional | 05/14/1980SE |
| K800101 | 4200 Me EchoencephalographIYO · Traditional | 05/02/1980SE |
| K800092 | Combison ComputerDQK · Traditional | 04/08/1980SE |
| K800100 | 7200 Ma Echo-OphthalmoscopeIYO · Traditional | 02/21/1980SE |
| K800099 | Intracula IIIYO · Traditional | 02/21/1980SE |
| K800098 | Minifeton 200KNG · Traditional | 02/11/1980SE |
| K800097 | Minivason 9JAF · Traditional | 02/11/1980SE |
| K800096 | Ambivason DR-200JAF · Traditional | 02/11/1980SE |
| K800094 | Combison 200 & Combison 202IYO · Traditional | 02/11/1980SE |
Questions and answers
When was MGD-3 cleared by the FDA?
MGD-3 (K800095) received a 510(k) decision of Substantially Equivalent on February 11, 1980, 28 days after the submission was received.
What is the product code of K800095?
The FDA product code is KNG – Monitor, Ultrasonic, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.2660.