The following data is part of a premarket notification filed by Integra Lifesciences Production Corporation with the FDA for Cerelink Icp Monitor.
| Device ID | K210993 |
| 510k Number | K210993 |
| Device Name: | CereLink ICP Monitor |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield, MA 02048 |
| Contact | Marybeth Carson |
| Correspondent | Marybeth Carson Integra LifeSciences Production Corporation 11 Cabot Boulevard Mansfield, MA 02048 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-02 |
| Decision Date | 2021-04-30 |