The following data is part of a premarket notification filed by Visible Patient, Sas with the FDA for Visible Patient Suite.
Device ID | K212896 |
510k Number | K212896 |
Device Name: | Visible Patient Suite |
Classification | System, Image Processing, Radiological |
Applicant | Visible Patient, SAS 8 Rue Gustave Adolphe HIRN Strasbourg, FR 67000 |
Contact | Emeline Degivry |
Correspondent | John J Smith Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-10 |
Decision Date | 2021-11-05 |