The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Pressure Wire Sensor, Models 12003/12303, 12004/12304.
| Device ID | K022187 |
| 510k Number | K022187 |
| Device Name: | PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304 |
| Classification | Transducer, Pressure, Catheter Tip |
| 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 | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-05 |
| Decision Date | 2002-09-24 |
| Summary: | summary |