The following data is part of a premarket notification filed by Envizion Medical Ltd. with the FDA for Envizion Medical Envue; Envizion Medical Enteral Feeding Tube.
| Device ID | K182915 |
| 510k Number | K182915 |
| Device Name: | ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ENvizion Medical Ltd. 7 Haarad St Tel Aviv, IL 6971060 |
| Contact | Doron Besser |
| Correspondent | Clay Anselmo Shriner & Associates 429 Whitepine Creek Road Trout Creek, MT 59874 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-18 |
| Decision Date | 2019-02-13 |
| Summary: | summary |