The following data is part of a premarket notification filed by Rapid Biomedical Gmbh with the FDA for P-140-flex Coil, Na-140-flex Coil, C-140-flex Coil.
| Device ID | K163661 |
| 510k Number | K163661 |
| Device Name: | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | RAPID Biomedical GmbH Kettelerstr. 3-11 Rimpar, DE 97222 |
| Contact | Christian Zimmermann |
| Correspondent | Christian Zimmermann RAPID Biomedical GmbH Kettelerstr. 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 | 2016-12-27 |
| Decision Date | 2018-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260487680010 | K163661 | 000 |
| 04260487680089 | K163661 | 000 |
| 04260487680072 | K163661 | 000 |
| 04260487680546 | K163661 | 000 |
| 04260487680539 | K163661 | 000 |