The following data is part of a premarket notification filed by Rapid Biomedical Gmbh with the FDA for 31p/1h Head Coil 3t; 23na/1h Head Coil 3t; 13c/1h Head Coil 3t.
| Device ID | K102748 |
| 510k Number | K102748 |
| Device Name: | 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | RAPID BIOMEDICAL GMBH KETTELERSTR. 3-11 TECHNOLOGIEPARK WUERZBURG-RIMP Rimpar, Bavaria, DE 97222 |
| Contact | Armin Purea |
| Correspondent | Armin Purea RAPID BIOMEDICAL GMBH KETTELERSTR. 3-11 TECHNOLOGIEPARK WUERZBURG-RIMP Rimpar, Bavaria, DE 97222 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-23 |
| Decision Date | 2011-05-13 |
| Summary: | summary |