The following data is part of a premarket notification filed by Envizion Medical Ltd. with the FDA for Envizion Medical Envue System, Envizion Medical Enteral Feeding Tube.
Device ID | K191387 |
510k Number | K191387 |
Device Name: | ENvizion Medical ENVue SYSTEM, 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 59872 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-24 |
Decision Date | 2019-06-14 |