The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Pressurewire Sensor, Model #12001.
| Device ID | K983506 |
| 510k Number | K983506 |
| Device Name: | PRESSUREWIRE SENSOR, MODEL #12001 |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-07 |
| Decision Date | 1999-02-03 |
| Summary: | summary |