FDA device listing
2MHz CW Water Proof Probe; 2MHz Normal Probe; 3MHz CW Normal Probe; 3MHz CW Water Proof Probe;,Baby Sound A Pocket Fetal…
FDA device listing 1364416144 · CONTEC MEDICAL SYSTEMS CO., LTD
Key facts
| Proprietary names | 2MHz CW Water Proof Probe; 2MHz Normal Probe; 3MHz CW Normal Probe; 3MHz CW Water Proof Probe;,Baby Sound A Pocket Fetal Doppler,Baby Sound B Pocket Fetal Doppler,Baby Sound C Pocket Fetal Doppler,Sonoline A Pocket Fetal Doppler,Sonoline B Pocket Fetal Doppler |
|---|---|
| Owner/operator | CONTEC MEDICAL SYSTEMS CO., LTD |
| Owner/operator number | 10025156 |
| Premarket submissions | K082480 |
| Product codes | KNG |
| Device names | KNG - Monitor, Ultrasonic, Fetal |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.2660 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | CONTEC MEDICAL SYSTEMS CO., LTD |
| Establishment registrations | 3006979678 |
| FEI numbers | 3006979678 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database