The following data is part of a premarket notification filed by Etview Ltd. with the FDA for Vivasight-dl System.
| Device ID | K123853 |
| 510k Number | K123853 |
| Device Name: | VIVASIGHT-DL SYSTEM |
| Classification | Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) |
| Applicant | ETVIEW LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy ETVIEW LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | CBI |
| CFR Regulation Number | 868.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-14 |
| Decision Date | 2013-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290013745730 | K123853 | 000 |
| 27290013745723 | K123853 | 000 |
| 27290013745716 | K123853 | 000 |
| 27290013745709 | K123853 | 000 |
| 27290013745624 | K123853 | 000 |
| 17290013745610 | K123853 | 000 |
| 07290013745606 | K123853 | 000 |
| 07290013745590 | K123853 | 000 |