The following data is part of a premarket notification filed by Moon Surgical with the FDA for Maestro Platform.
Device ID | K221410 |
510k Number | K221410 |
Device Name: | Maestro Platform |
Classification | Table, Operating-room, Ac-powered |
Applicant | Moon Surgical c/o Sofinnova Partners, 7/11 Bd Haussmann Paris, FR 75009 |
Contact | Anne Osdoit |
Correspondent | Michael Daniel Daniel & Daniel Consulting 340 Jones Lane Gardnerville, NV 89460 |
Product Code | FQO |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-05-16 |
Decision Date | 2022-12-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MAESTRO PLATFORM 87394786 5333987 Live/Registered |
MAESTRO, INC. 2017-03-31 |