Data / Medical devices / United States / Alcove Medical, Inc.
Alcove Medical, Inc.: FDA-registered device maker in Cedar City, UT, United States, 1 510(k) clearance
Alcove Medical, Inc. is registered with the FDA (registration 3046548163) in Cedar City, UT, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 23, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3046548163
- Address
- 2318 N Wonser, Cedar City, UT, United States, 84721
- Owner or operator
- Alcove Medical, Inc. (10038168)
- Roles
- Manufacturer
- First device listed
- September 21, 2011
- Registered through
- 2026
- Brand names listed
- EZ-SPRAY
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | 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 23, 1997 | K972397 | EZ SPRAY | CCQ | Substantially Equivalent | Intertex Research, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 23, 1997. 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.