510(k) DEN210052
- Device
- Vibrant System
- Applicant
- Vibrant, Ltd.
- 510(k) number
- DEN210052
- Product code
- QTN
- Decision
- Unknown (DENG)
- Decision date
- 2022-08-26
- Date received
- 2021-11-30
- Regulation
- 876.5940
- Classification name
- Orally Ingested Transient Device For Constipation
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Lior Ben Tsur
- Address
- Hakochav P.O. Box 516 Yokneam IL 2069206 2069206
FDA Registration Numbers#
- 3011782009
- 3025305436
Source Documents#
510(k) summary PDF not indicated by FDA