510(k) K191387
K191387 is an FDA 510(k) premarket notification submitted by Envizion Medical , Ltd. for the device "ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube". The FDA issued a decision of Substantially Equivalent on Jun 14, 2019. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Envizion Medical , Ltd. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 14, 2019
- Date Received
- May 24, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)