Identifiers
- 510(k) Number
- K162392 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Avazzia is a neurology device classified under product code NUH. It is designed for use in neurological applications and has been determined to be substantially equivalent to predicate devices.
The device is supplied by Avazzia, Inc. located in Dallas, Texas. It received FDA 510(k) clearance with number K162392 on May 12, 2017, and was reviewed by the Neurology advisory committee. The device is intended for single-use or multiple-use applications, though specific sterility and MRI safety information are not provided in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162392 | Class II | Active |
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Manufacturer
- Manufacturer
- Avazzia, Inc.
Sources (1)
- FDA 510(k) K162392 24 fields · synced Sep 22, 2026