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 |