Identifiers
- 510(k) Number
- K160578 FDA 510(k)
- FDA Product Code
- QSY FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Nustat XR by Beeken Biomedical LLC — U — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160578 | U | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beeken Biomedical LLC
- FDA Applicant
- Beeken Biomedical, LLC
Sources (1)
- FDA 510(k) K160578 24 fields · synced Jun 19, 2026