Data / Medical devices / China / Shenzhen Yimi Life Technology Co.,ltd
Shenzhen Yimi Life Technology Co.,ltd: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Yimi Life Technology Co.,ltd is registered with the FDA (registration 3016171841) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016171841
- Address
- 302 Building C,YouLiTong Industrial Plant,No.56 Qingsong Road,Laokeng Community,Longtian Street, Pingshan, Shenzhen Guangdong, China, 518118
- Owner or operator
- Shenzhen Yimi Life Technology Co.,Ltd (10061585)
- Roles
- Manufacturer
- First device listed
- October 31, 2019
- Registered through
- 2026
- Brand names listed
- Ease Healthcare YM301, Night O2 Pulse Oximeter, Oximeter, YM101S; YM102S; YM301S; YM201S; YM301S; YM101; YM102; YM103; YM201; YM301, PandaPulse, YM101 Pulse Oximeter, YM102 Pulse Oximeter, YM103 Pulse Oximeter, YM104 Pulse Oximeter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 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 |
|---|---|---|---|---|---|---|
| October 25, 2024 | K240092 | Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) | DQA | Substantially Equivalent | Shenzhen Yimi Life Technology Co., Ltd. | accessdata.fda.gov |
| October 18, 2019 | K191430 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Yimi Life-Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated October 25, 2024. 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.