The following data is part of a premarket notification filed by Noras Rontgen-und Medizintechnik Gmbh with the FDA for 16 Ch Multipurpose Coil Variety.
| Device ID | K140252 |
| 510k Number | K140252 |
| Device Name: | 16 CH MULTIPURPOSE COIL VARIETY |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NORAS RONTGEN-UND MEDIZINTECHNIK GMBH LEIBNIZSTRASSE 4 Hochberg, DE 97204 |
| Contact | Zahed Sedighiani |
| Correspondent | Zahed Sedighiani NORAS RONTGEN-UND MEDIZINTECHNIK GMBH LEIBNIZSTRASSE 4 Hochberg, DE 97204 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-31 |
| Decision Date | 2014-05-08 |
| Summary: | summary |