Data / Medical devices / United States / Valensil
Valensil: FDA-registered device maker in Avon, OH, United States, 1 510(k) clearance
Valensil is registered with the FDA (registration 3016609920) in Avon, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated February 21, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016609920
- Address
- 34910 Commerce Way, Avon, OH, United States, 44011
- Owner or operator
- Valensil (10062875)
- Roles
- Manufacturer
- First device listed
- March 12, 2020
- Registered through
- 2027
- Brand names listed
- ULTepap
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea | OHP | 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 |
|---|---|---|---|---|---|---|
| February 21, 2020 | K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | OHP | Substantially Equivalent | Bryggs Medical, LLC | accessdata.fda.gov |
Compare with other makers
Updated February 21, 2020. 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.