Data / Medical devices / China / GVS Technology (Suzhou) Co., Ltd
GVS Technology (Suzhou) Co., Ltd: FDA-registered device maker in Suzhou Jiangsu, China, 3 510(k) clearances
GVS Technology (Suzhou) Co., Ltd is registered with the FDA (registration 3005855942) in Suzhou Jiangsu, China. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 1, 2005. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005855942
- Address
- No.8 Taishan Road Suzhou New District SND, Suzhou Jiangsu, China, 215129
- Owner or operator
- GVS Technology (Suzhou) Co., Ltd (10032971)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 30, 2010
- Registered through
- 2026
- Brand names listed
- 100, 1420, 1600, 1898/711KBSBB, 2800, 300, 3000, 3200 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Carbon-Dioxide | BSF | 1 | Contract manufacturer | accessdata.fda.gov |
| Accessory To Continuous Ventilator (Respirator) | MOD | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| September 1, 2005 | K051712 | MODEL 2800 PFT FILTER | BZG | Substantially Equivalent | Air Safety, Ltd. | accessdata.fda.gov |
| June 3, 2004 | K040712 | AIR SAFETY HEPA, MODEL 3500 | MOD | Substantially Equivalent | Air Safety, Ltd. | accessdata.fda.gov |
| May 13, 2004 | K033008 | AIR SAFETY HEPA AND NON-HEPA FILTERS | CAH | Substantially Equivalent | Air Safety, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Absorber, Carbon-Dioxide
- All makers of Spirometer, Diagnostic
- All makers of Condenser, Heat And Moisture (Artificial Nose)
- All makers of Accessory To Continuous Ventilator (Respirator)
Updated September 1, 2005. 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.