Data / Medical devices / United States / Altor Safety
Altor Safety: FDA-registered device maker in Valley Cottage, NY, United States, 2 510(k) clearances
Altor Safety is registered with the FDA (registration 3016966810) in Valley Cottage, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 3, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016966810
- Address
- 711 Executive Blvd Suite C, Valley Cottage, NY, United States, 10989
- Owner or operator
- Altor Safety (10075017)
- Roles
- Manufacturer
- First device listed
- June 5, 2020
- Registered through
- 2026
- Brand names listed
- None
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | N | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 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 |
|---|---|---|---|---|---|---|
| September 3, 2021 | K211762 | Altor Safety 4-Ply Surgical Mask (Model:62232) | FXX | Substantially Equivalent | Altor Safety, LLC | accessdata.fda.gov |
| July 23, 2021 | K211249 | Altor Safety 3-Ply Surgical Mask (Model:62222) | FXX | Substantially Equivalent | Altor Safety, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
- All makers of Mask, Surgical
Updated September 3, 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.