The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Radianalyzer Xpress.
| Device ID | K092105 |
| 510k Number | K092105 |
| Device Name: | RADIANALYZER XPRESS |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE Se-754 50 |
| Contact | Mats Granlund |
| Correspondent | Mats Granlund RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE Se-754 50 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-14 |
| Decision Date | 2009-10-09 |
| Summary: | summary |