The following data is part of a premarket notification filed by Etview Ltd. with the FDA for Vivasight-dl System.
| Device ID | K181886 |
| 510k Number | K181886 |
| Device Name: | VivaSight-DL System |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | ETView Ltd. M.P Misgav Misgav Business Park, IL 2017900 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy Qsite 31 Haavoda St. Binyamina, IL 3054431 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-13 |
| Decision Date | 2018-11-14 |
| Summary: | summary |