Data / Medical devices / China / Jiangsu Konsung Bio-Medical Science And Technology Co Ltd
Jiangsu Konsung Bio-Medical Science And Technology Co Ltd: FDA-registered device maker in Danyang Jiangsu, China, 3 510(k) clearances
Jiangsu Konsung Bio-Medical Science And Technology Co Ltd is registered with the FDA (registration 3016859940) in Danyang Jiangsu, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 5, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3016859940
- Address
- No.8,Shengchang West Road, Danyang Development Zone, Danyang Jiangsu, China, 212300
- Owner or operator
- Jiangsu Konsung Bio-Medical Science And Technology Co.,Ltd. (10066875)
- Roles
- Manufacturer
- First device listed
- April 5, 2020
- Registered through
- 2027
- Brand names listed
- Fingertip Pulse Oximeter models SONOSAT-F01T, SONOSAT-F02T, SONOSAT-F02TR, SONOSAT-F02TW, SONOSAT-F02TL, SONOSAT-F02TP, Fingertip Pulse Oximeter models SONOSAT-F02T, SONOSAT-F02TR, SONOSAT-F02TW, SONOSAT-F02TL, SONOSAT-F02TP, Wrist Pulse Oximeter model SONOSAT-W01T, oxygen concentrator (Model: KSW-5, KSN-5, KSOC-5)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | 2 | Manufacturer | accessdata.fda.gov |
| 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 5, 2023 | K223740 | Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) | CAW | Substantially Equivalent | Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. | accessdata.fda.gov |
| August 18, 2016 | K152091 | Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | accessdata.fda.gov |
| August 17, 2016 | K152089 | Wrist Pulse Oximeter | DQA | Substantially Equivalent | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Oximeter, Infrared, Sporting, Aviation
- All makers of Generator, Oxygen, Portable
Updated October 5, 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.