FDA Product Code
FDA Product Code PCB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5560
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242034 | Duet External Drainage and Monitoring System (EDMS) | Medtronic Neurosurgery | 2024-10-24 | Special | PDF ↗ |
| DEN120017 | Medtronic DUET External Drainage and Monitoring System | Medtronic Neurosurgery | 2014-08-22 | Post-NSE | — |
Product code PCB · Class II · Neurology. Data: openFDA.