Prelude
System, Planning, Radiation Therapy Treatment
MedCom GmbH
The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Prelude.
Pre-market Notification Details
| Device ID | K180308 |
| 510k Number | K180308 |
| Device Name: | Prelude |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | MedCom GmbH Dolivostrasse 11 Darmstadt, DE 64293 |
| Contact | Johannes Messow |
| Correspondent | Johannes Messow MedCom GmbH Dolivostrasse 11 Darmstadt, DE 64293 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-02 |
| Decision Date | 2018-03-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260308110108 | K180308 | 000 |
| 04260308110092 | K180308 | 000 |
Trademark Results [Prelude]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.