The following data is part of a premarket notification filed by Etview Ltd. with the FDA for Viva Eb.
| Device ID | K120334 |
| 510k Number | K120334 |
| Device Name: | VIVA EB |
| 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 | 2012-02-03 |
| Decision Date | 2012-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290013745801 | K120334 | 000 |
| 17290013745795 | K120334 | 000 |
| 17290013745788 | K120334 | 000 |
| 17290013745771 | K120334 | 000 |
| 07290013745569 | K120334 | 000 |
| 07290013745552 | K120334 | 000 |
| 17290013745542 | K120334 | 000 |
| 07290013745514 | K120334 | 000 |