The following data is part of a premarket notification filed by Rapid Biomedical Gmbh with the FDA for 16ch Ai Breast Coils 1.5 T And 3 T.
| Device ID | K083255 |
| 510k Number | K083255 |
| Device Name: | 16CH AI BREAST COILS 1.5 T AND 3 T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | RAPID BIOMEDICAL GMBH KETTELERSTRASSE 3-11 Rimpar, Bayern, DE 97222 |
| Contact | Armin Purea |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-11-04 |
| Decision Date | 2008-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260487680041 | K083255 | 000 |
| 04260487680034 | K083255 | 000 |