The following data is part of a premarket notification filed by Integra Neurosciences with the FDA for Neurosensor Cerebral Blood Flow And Intracranial Pressure Monitoring Kit/system, Models Ns-p, Ns-100.
| Device ID | K050720 |
| 510k Number | K050720 |
| Device Name: | NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | INTEGRA NEUROSCIENCES 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Nancy A Mathewson |
| Correspondent | Nancy A Mathewson INTEGRA NEUROSCIENCES 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-21 |
| Decision Date | 2005-05-11 |
| Summary: | summary |