The following data is part of a premarket notification filed by Cma Microdialysis Ab with the FDA for Modification To Cma Cerebral Tissue Monitoring System.
| Device ID | K102077 |
| 510k Number | K102077 |
| Device Name: | MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | CMA MICRODIALYSIS AB 73 PRINCETON STREET North Chelmsford, MA 01863 |
| Contact | Nancy Blanco |
| Correspondent | Nancy Blanco CMA MICRODIALYSIS AB 73 PRINCETON STREET North Chelmsford, MA 01863 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-23 |
| Decision Date | 2011-01-14 |
| Summary: | summary |