Data / Medical devices / China / Solaris Medical Technology, Inc.
Solaris Medical Technology, Inc.: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Solaris Medical Technology, Inc. is registered with the FDA (registration 3006552505) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 7, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006552505
- Address
- Zhongjian Industrial Building One #401 18 Yanshan Road, Shekou, Nanshan District, Shenzhen Guangdong, China, 518067
- Owner or operator
- Solaris Medical Technology, Inc. (10025740)
- Roles
- Manufacturer
- First device listed
- May 5, 2008
- Registered through
- 2026
- Brand names listed
- SOLARIS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 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 7, 2010 | K100077 | NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 | DQA | Substantially Equivalent | Solaris Medical Technology, Inc. | accessdata.fda.gov |
| July 22, 2010 | K101972 | SOLARIS REUSABLE AND DISPOSABLE BLOOD PRESSURE CUFFS | DXQ | Substantially Equivalent | Solaris Medical Technology, Inc. | accessdata.fda.gov |
| January 31, 2007 | K061931 | SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 | DQA | Substantially Equivalent | Solaris Medical Technology, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 7, 2010. 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.