The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for Noras Cpc Multifunctional Coil.
| Device ID | K083578 |
| 510k Number | K083578 |
| Device Name: | NORAS CPC MULTIFUNCTIONAL COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NORAS MRI PRODUCTS GMBH LEIBNITZSTRASSE 4 Hoechberg, DE 97204 |
| Contact | Zahed Sedighiani |
| Correspondent | Zahed Sedighiani NORAS MRI PRODUCTS GMBH LEIBNITZSTRASSE 4 Hoechberg, DE 97204 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-03 |
| Decision Date | 2009-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251269201547 | K083578 | 000 |
| 04251269201530 | K083578 | 000 |
| 04251269201523 | K083578 | 000 |
| 04251269201516 | K083578 | 000 |
| 04251269201493 | K083578 | 000 |
| 04251269201486 | K083578 | 000 |
| 04251269200311 | K083578 | 000 |