Data / Medical devices / France / Aqua-Tools
Aqua-Tools: FDA-registered device maker in Paris Yvelines, France, 1 510(k) clearance
Aqua-Tools is registered with the FDA (registration 3014640782) in Paris Yvelines, France. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 25, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014640782
- Address
- 11 rue Lobineau, Paris Yvelines, France, 75006
- Owner or operator
- Aqua-tools (10062561)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- February 13, 2020
- Registered through
- 2026
- Brand names listed
- FILT'RAY2G
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Water Purification, General Medical Use | NHV | 2 | Complaint file establishment, Specification developer | 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, 2019 | K191563 | FILTRAY 2G Disposable Water Filters | NHV | Substantially Equivalent | Aqua-Tools | accessdata.fda.gov |
Compare with other makers
Updated October 25, 2019. 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.