The following data is part of a premarket notification filed by Etview Ltd. with the FDA for Tracheoscopic Ventilation Tube (tvt) System.
| Device ID | K052233 |
| 510k Number | K052233 |
| Device Name: | TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | ETVIEW LTD. 31 HAAVODA ST. Binyamina, IL |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy ETVIEW LTD. 31 HAAVODA ST. Binyamina, IL |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-17 |
| Decision Date | 2005-12-13 |
| Summary: | summary |