The following data is part of a premarket notification filed by Etview with the FDA for Tracheoscopic Ventilation Tube (tvt).
| Device ID | K082420 |
| 510k Number | K082420 |
| Device Name: | TRACHEOSCOPIC VENTILATION TUBE (TVT) |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | ETVIEW 31 HAAVODA ST Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy ETVIEW 31 HAAVODA ST Binyamina, IL 30500 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-22 |
| Decision Date | 2008-10-08 |
| Summary: | summary |