The following data is part of a premarket notification filed by Etview Ltd. with the FDA for Double Lumen Video Tracheosdope (dlvt) System.
| Device ID | K113576 |
| 510k Number | K113576 |
| Device Name: | DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) 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 | 2011-12-05 |
| Decision Date | 2012-05-18 |
| Summary: | summary |