Data / Medical devices / China / Shenzhen Fitconn Technology Co., Ltd
Shenzhen Fitconn Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Fitconn Technology Co., Ltd is registered with the FDA (registration 3015219192) in Shenzhen Guangdong, China. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 14, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015219192
- Address
- 7th, Floor No.116 xiangshan road, luotian community, songgang street, Baoan, Shenzhen Guangdong, China, 518105
- Owner or operator
- Shenzhen Fitconn Technology Co., Ltd (10059755)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- February 20, 2019
- Registered through
- 2027
- Brand names listed
- Anti Decubitus Mattress models FU-AM001,FU-AM001L,FU-AM002,FU-AM003,FU-AM004,FU-AM005,FU-AM006, CDC100,CDC100B,CDC200,CDC200S,CDC300S,CDC500,CDC500S, CDC500B, CDC100,CDC100B,CDC200,CDC200S,CDC300S,CDC500,CDC500S, CDC500B, CNB69012, CNB69015, CNB69016, CNB69017, CNB69012, CNB69015, CNB69016, CNB69017, CNB69018, CNB69020, CNB69021, CNB69022, CNB69025, CNB69021S, CNB69025S, CNB69026, CNB69018, CNB69020, CNB69021, CNB69022, CNB69025, CNB69021S, CNB69025S, CNB69026, CNB69028, CNB69029, CNB69028, CNB69029, CNB69029S, CNB69031, CNB69031S, CNB69029S, CNB69031, CNB69031S,CNB69006,CNB69007,CNB69008,CNB69009,CNB69010, CNB69011, COMPRESSOR NEBULIZER, Models: CNB69006,CNB69007,CNB69008,CNB69009,CNB69010, CNB69011 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Compressor, Air, Portable | BTI | 2 | Manufacturer | accessdata.fda.gov |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | 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 |
|---|---|---|---|---|---|---|
| June 14, 2021 | K201397 | Ultrasonic Mesh Nebulizer | CAF | Substantially Equivalent | Shenzhen Ivankaca Technology Co., Ltd. | accessdata.fda.gov |
| November 10, 2009 | K091272 | BESMED JET NEBULIZER BOTTLE SET | CAF | Substantially Equivalent | Besmed Health Business Corp | accessdata.fda.gov |
Compare with other makers
- All makers of Compressor, Air, Portable
- All makers of Mattress, Air Flotation, Alternating Pressure
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Catheters, Suction, Tracheobronchial
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Updated June 14, 2021. 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.