The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Pressurewire Certus, Certus (300cm), Aeris, Aeris (300cm), Receiver.
| Device ID | K080813 |
| 510k Number | K080813 |
| Device Name: | PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Contact | Bjorn Palmgren |
| Correspondent | Bjorn Palmgren RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-21 |
| Decision Date | 2008-07-01 |
| Summary: | summary |