FDA Product Code
FDA Product Code QSL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1565
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN200042 | BrainTemp Neonate System (BTNeo System) | Brain Temp, Inc. | 2022-03-29 | Direct | — |
Product code QSL · Class II · Neurology. Data: openFDA.