The following data is part of a premarket notification filed by Medivis, Inc. with the FDA for Surgicalar.
Device ID | K190764 |
510k Number | K190764 |
Device Name: | SurgicalAR |
Classification | System, Image Processing, Radiological |
Applicant | MEDIVIS, Inc. 20 Jay Street Suite 312 Brooklyn, NY 11201 |
Contact | Amy Lynn |
Correspondent | Amy Lynn MEDIVIS, Inc. 20 Jay Street Suite 312 Brooklyn, NY 11201 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-25 |
Decision Date | 2019-05-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SURGICALAR 88305582 5923066 Live/Registered |
Medivis, Inc. 2019-02-18 |