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 |