Data / Medical devices / China / Chilecom Medical Devices Co Ltd
Chilecom Medical Devices Co Ltd: FDA-registered device maker in Xiangtan Hunan, China, 1 510(k) clearance
Chilecom Medical Devices Co Ltd is registered with the FDA (registration 3007728072) in Xiangtan Hunan, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 13, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007728072
- Address
- 38 Shuyuan Road Yuetang District, Xiangtan Hunan, China, 411101
- Owner or operator
- Chilecom Medical Device Co., Ltd. (10023030)
- Roles
- Manufacturer
- First device listed
- March 11, 2009
- Registered through
- 2026
- Brand names listed
- Chilecom, Chilecom Endotracheal Tubes, Super Jet Nebs, SuperJetNeb, SuperNeb, SuperNebs, Tracheal tube stylet, chilecom
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Nebulizer, Electrically Powered | JPW | 1 | Manufacturer | accessdata.fda.gov |
| Stylet, Tracheal Tube | BSR | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Tracheal (W/Wo Connector) | BTR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2009 | K080105 | ENDOTRACHEAL TUBE | BTR | Substantially Equivalent | Chilecom Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Nebulizer, Electrically Powered
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- All makers of Stylet, Tracheal Tube
- All makers of Tube, Tracheal (W/Wo Connector)
- All makers of Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Updated February 13, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.