The following data is part of a premarket notification filed by Etview Ltd. with the FDA for Etview Vivasight-sl (tvt) System.
| Device ID | K152438 |
| 510k Number | K152438 |
| Device Name: | ETView VivaSight-SL (TVT) System |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | ETVIEW LTD. M.P MISGAV Misgav Business Park, IL 201790 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy QSITE 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-27 |
| Decision Date | 2016-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290013745761 | K152438 | 000 |
| 27290013745754 | K152438 | 000 |
| 27290013745747 | K152438 | 000 |
| 07290013745026 | K152438 | 000 |
| 27290013745013 | K152438 | 000 |
| 07290013745002 | K152438 | 000 |