The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Modification To: Radianalyzer, Model 12711.
| Device ID | K042628 |
| 510k Number | K042628 |
| Device Name: | MODIFICATION TO: RADIANALYZER, MODEL 12711 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Contact | Helene Ekstrand |
| Correspondent | Helene Ekstrand RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-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 | 2004-09-27 |
| Decision Date | 2005-01-19 |
| Summary: | summary |