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GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71 - Gimmi Alpha Sinuscopes Model # E.8282.01/31/71 + E.8284.01/31/71
FDA 510(k)Class II (US FDA 510(k))
510(k) K013731
by Gimmi GmbH
Identifiers
- 510(k) Number
- K013731 FDA 510(k)
- FDA Product Code
- EOQ FDA 510(k)
- Models / Variants
- Gimmi Alpha Sinuscopes Model # E.8282.01/31/71 + E.8284.01/31/71 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4680 FDA 510(k)
- Regulation Number
- 874.4680 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71 - Gimmi Alpha Sinuscopes Model # E.8282.01/31/71 + E.8284.01/31/71 by Gimmi GmbH — Class II…
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 | K013731 | Class II | Active |
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Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (1)
- FDA 510(k) K013731 24 fields · synced Jun 18, 2026