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Sign in to claim this brandDk Medical Systems Co., Ltd.
US
Last updated May 23, 2026
What Dk Medical Systems Co., Ltd. makes
Dk Medical Systems Co., Ltd. manufactures the INNOVISION-P5 and INNOVISION-DXII, which are likely endoscopic imaging systems for medical procedures, and the AeroDR TX c02, a device designed for respiratory support or diagnostic imaging of the airway.
These products are classified as Class II devices under FDA regulations and are listed in the 510(k) clearance registry. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Dk Medical Systems Co., Ltd. manufacture?
Dk Medical Systems Co., Ltd. manufactures medical devices including the INNOVISION-P5 and INNOVISION-DXII, which appear to be endoscopic imaging systems used during surgical or diagnostic procedures. They also produce the AeroDR TX c02, likely a device for respiratory support or airway imaging. These products are designed to assist healthcare professionals in visualizing internal body structures or delivering targeted respiratory care.
Where is Dk Medical Systems Co., Ltd. based?
Dk Medical Systems Co., Ltd. is based in the United States. The company’s headquarters or primary operational location is within the country, though specific regional details are not provided.
Which regulatory registries list devices manufactured by Dk Medical Systems Co., Ltd.?
Devices from Dk Medical Systems Co., Ltd. are listed in the FDA’s 510(k) clearance registry. This registry includes devices that have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring compliance with FDA regulations.
How are devices from Dk Medical Systems Co., Ltd. classified under FDA regulations?
The devices manufactured by Dk Medical Systems Co., Ltd., such as the INNOVISION-P5, INNOVISION-DXII, and AeroDR TX c02, are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls in addition to general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DAEHAN Disposable cup electrode | DCW 30C | FDA UDI | Class II | Active |
| DMS Disposable Subdermal Needle Electrodes | K161566 | FDA 510(k) | Class II | Active |
| DAEHAN Adhesive Surface Electrodes | K180247 | FDA 510(k) | Class II | Active |
| Innovision-P5 | K250750 | FDA 510(k) | Class II | Active |
| Extracorporeal Shock Wave Lithotripter, Comed Asadal-M1 | K131721 | FDA 510(k) | Class II | Active |
| Innovision-Dxii | K250790 | FDA 510(k) | Class II | Active |
| DAEHAN Disposable CUP Electrodes | K180232 | FDA 510(k) | Class II | Active |
| AeroDR TX c02 | K253446 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (2)
Establishments registered with the FDA under this company group, matched by name.
- Daehan Medical Systems Co., Ltd Siheung-City Gyeonggi · KR FEI 3002893037
- Dk Medical Systems Co., Ltd. Pyeongtaek-si Gyeonggi · KR FEI 3014403439