The following data is part of a premarket notification filed by Etview Ltd. with the FDA for Etview Tracheoscopic Ventilation Tube (tvt(tm)).
| Device ID | K121028 |
| 510k Number | K121028 |
| Device Name: | ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) |
| Classification | Tube, Tracheal (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 | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-05 |
| Decision Date | 2012-06-21 |
| Summary: | summary |