The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Radianalyzer, Model 12710, Radiview (pc-software Accessory), Model 12720.
| Device ID | K013943 |
| 510k Number | K013943 |
| Device Name: | RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 |
| Classification | Computer, Blood-pressure |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Contact | Mats Granlund |
| Correspondent | Mats Granlund RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-29 |
| Decision Date | 2001-12-18 |
| Summary: | summary |