The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for Noras Or Head Holder Flexibility.
| Device ID | K133506 |
| 510k Number | K133506 |
| Device Name: | NORAS OR HEAD HOLDER FLEXIBILITY |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-14 |
| Decision Date | 2014-08-06 |
| Summary: | summary |