The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for Noras Or Head Holder S17000-mq/ Noras Or Head Coil 3t 7230-ph Model S1700-mq/ 7230-ph.
| Device ID | K093693 |
| 510k Number | K093693 |
| Device Name: | NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH |
| 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 | 2009-11-30 |
| Decision Date | 2010-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251269205323 | K093693 | 000 |
| 04251269205934 | K093693 | 000 |
| 04251269205927 | K093693 | 000 |
| 04251269205910 | K093693 | 000 |
| 04251269205903 | K093693 | 000 |
| 04251269206184 | K093693 | 000 |
| 04251269206177 | K093693 | 000 |
| 04251269206924 | K093693 | 000 |
| 04251269206917 | K093693 | 000 |
| 04251269206900 | K093693 | 000 |
| 04251269206894 | K093693 | 000 |
| 04251269206887 | K093693 | 000 |
| 04251269206870 | K093693 | 000 |
| 04251269206863 | K093693 | 000 |
| 04251269203701 | K093693 | 000 |
| 04251269204890 | K093693 | 000 |
| 04251269205118 | K093693 | 000 |
| 04251269205101 | K093693 | 000 |
| 04251269205095 | K093693 | 000 |
| 04251269205088 | K093693 | 000 |
| 04251269205002 | K093693 | 000 |
| 04251269204999 | K093693 | 000 |
| 04251269204968 | K093693 | 000 |
| 04251269204951 | K093693 | 000 |
| 04251269204944 | K093693 | 000 |
| 04251269204937 | K093693 | 000 |
| 04251269204920 | K093693 | 000 |
| 04251269204913 | K093693 | 000 |
| 04251269204906 | K093693 | 000 |
| 04251269206856 | K093693 | 000 |