Data / Medical devices / China / Shenzhen Witleaf Medical Electronics Co., Ltd.
Shenzhen Witleaf Medical Electronics Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Witleaf Medical Electronics Co., Ltd. is registered with the FDA (registration 3020924771) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 26, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020924771
- Address
- Room 1201, Building 1, Senyang Electronic Technology Park, West Area, Guangming High-tech Park Tianliao Community, Yutang Street, Guangming District, Shenzhen Guangdong, China, 518132
- Owner or operator
- Shenzhen Witleaf Medical Electronics Co., Ltd. (10087479)
- Roles
- Manufacturer
- First device listed
- March 4, 2023
- Registered through
- 2026
- Brand names listed
- Fingertip Pulse Oximeter (model: WIT-S200, WIT-S400), Handheld Pulse Oximeter (model: WIT-S100, WIT-S300, CH-100B), Handheld Pulse Oximeter CH-100; Wellness Oximeter, Nasopharyngeal airway for oxygenation and capnography (model: iway 13, iway 15), Pulse Oximeter (model: CH-100)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airway, Nasopharyngeal | BTQ | 1 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Wellness | PGJ | 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 26, 2023 | K213431 | Handheld Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Witleaf Medical Electronics Co., Ltd. | accessdata.fda.gov |
| December 30, 2022 | K213430 | Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Witleaf Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Airway, Nasopharyngeal
- All makers of Oximeter
- All makers of Oximeter, Wellness
- All makers of Oximeter, Infrared, Sporting, Aviation
Updated February 26, 2023. 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.