The following data is part of a premarket notification filed by Medcom Gmbh with the FDA for Verisuite.
Device ID | K181789 |
510k Number | K181789 |
Device Name: | VeriSuite |
Classification | System, Radiation Therapy, Charged-particle, Medical |
Applicant | MedCom GmbH Dolivostrasse 11 Darmstadt, DE 64293 |
Contact | Johannes Messow |
Correspondent | Johannes Messow MedCom GmbH Dolivostrasse 11 Darmstadt, DE 64293 |
Product Code | LHN |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-07-05 |
Decision Date | 2018-09-21 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VERISUITE 75761964 2535342 Dead/Cancelled |
Verida Internet Corp. 1999-07-27 |