The following data is part of a premarket notification filed by Rapid Biomedical Gmbh with the FDA for 1.5t Endorectal Coil, 3.0t Endorectal Coil, Er Coil Support.
| Device ID | K191539 |
| 510k Number | K191539 |
| Device Name: | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Rapid Biomedical GmbH Kettelerstrasse 3-11 Rimpar, DE 97222 |
| Contact | Christian Zimmermann |
| Correspondent | Christian Zimmermann Rapid Biomedical GmbH Kettelerstrasse 3-11 Rimpar, DE 97222 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-10 |
| Decision Date | 2020-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260487680447 | K191539 | 000 |
| 04260487680430 | K191539 | 000 |
| 04260487680423 | K191539 | 000 |
| 04260487680416 | K191539 | 000 |
| 04260487680249 | K191539 | 000 |
| 04260487680232 | K191539 | 000 |