Data / Medical devices / China / Shenzhen Ivankaca Technology Co.,ltd
Shenzhen Ivankaca Technology Co.,ltd: FDA-registered device maker in shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Ivankaca Technology Co.,ltd is registered with the FDA (registration 3020638914) in shenzhen Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 14, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020638914
- Address
- floor 3, building C3, hongdehui Industrial Zone, No. 128, Kangqiao Road, Nanwan street, Longgang District, shenzhen Guangdong, China, 518114
- Owner or operator
- Shenzhen Ivankaca Technology Co.,Ltd (10082876)
- Roles
- Manufacturer
- First device listed
- October 10, 2021
- Registered through
- 2026
- Brand names listed
- MY-123, MY-125, MY-126, MY-130, MY-132B, MY-135B, MY-136B, Medicinal Non-Ventilatory Nebulizer (Atomizer) : MY-123-1; MY-125-1; MY-126-1; MY-127-1; MY-128-1; MY-129-1 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
Compare with other makers
- All makers of Nebulizer (Direct Patient Interface)
- 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.