The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Pressurewire Certus, Models 12006 And 12306.
| Device ID | K062769 |
| 510k Number | K062769 |
| Device Name: | PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 |
| Classification | Transducer, Pressure, Catheter Tip |
| 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 | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-15 |
| Decision Date | 2006-12-04 |
| Summary: | summary |