The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for Noras Mr-bi320-pa 3t.
| Device ID | K082373 |
| 510k Number | K082373 |
| Device Name: | NORAS MR-BI320-PA 3T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NORAS MRI PRODUCTS GMBH LEIBNITZSTRASSE 4 Hoechberg, DE 97204 |
| Contact | Patricia Krapf |
| Correspondent | Stefan Preiss TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-08-18 |
| Decision Date | 2008-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251269205309 | K082373 | 000 |
| 04251269205293 | K082373 | 000 |
| 04251269205286 | K082373 | 000 |
| 04251269203503 | K082373 | 000 |
| 04251269201615 | K082373 | 000 |
| 04251269200243 | K082373 | 000 |
| 04251269200236 | K082373 | 000 |
| 04251269200175 | K082373 | 000 |
| 04251269207006 | K082373 | 000 |