Part 882 Subpart C
FDA submissions for Part 882 Subpart C in the Neurology (NE) review panel, including product codes, regulations, and recent device decisions.
Section range: § 882.2000
CFR Part: 882
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| SHO | Parkinsonian Syndrome Diagnostic Aid | 882.2000 | 2 | 1 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| DEN240071 | neuropacs | Automated Imaging Diagnostics, LLC | Apr 3, 2026 |
