The following data is part of a premarket notification filed by O3 Enterprise Srl with the FDA for Zeeromed View.
Device ID | K200546 |
510k Number | K200546 |
Device Name: | ZeeroMED View |
Classification | System, Image Processing, Radiological |
Applicant | O3 Enterprise SRL Padriciano 99 Tieste, IT 34149 |
Contact | Andrea Poli |
Correspondent | Jorge Millan Sigma Biomedical 7600 NW 69th Avenue Medley, FL 33166 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-03 |
Decision Date | 2020-05-05 |