The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for Noras Or Head Coil 3t, Models Si7200/si72100/si7220/si7230.
| Device ID | K091546 |
| 510k Number | K091546 |
| Device Name: | NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-27 |
| Decision Date | 2009-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251269204982 | K091546 | 000 |
| 04251269206801 | K091546 | 000 |
| 04251269206832 | K091546 | 000 |
| 04251269206849 | K091546 | 000 |
| 04251269206207 | K091546 | 000 |
| 04251269205897 | K091546 | 000 |
| 04251269200380 | K091546 | 000 |
| 04251269202605 | K091546 | 000 |
| 04251269202612 | K091546 | 000 |
| 04251269202629 | K091546 | 000 |
| 04251269203732 | K091546 | 000 |
| 04251269203749 | K091546 | 000 |
| 04251269206795 | K091546 | 000 |