The following data is part of a premarket notification filed by Akesis Inc with the FDA for Akesis Galaxy.
Device ID | K190844 |
510k Number | K190844 |
Device Name: | Akesis Galaxy |
Classification | System, Radiation Therapy, Radionuclide |
Applicant | Akesis Inc 5129 Commercial Circle Concord, CA 94520 |
Contact | Christopher Brown |
Correspondent | Christopher Brown Akesis Inc 5129 Commercial Circle Concord, CA 94520 |
Product Code | IWB |
CFR Regulation Number | 892.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-01 |
Decision Date | 2019-09-04 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AKESIS GALAXY 88235895 not registered Live/Pending |
Akesis, Inc. 2018-12-19 |