510(k) K232830
- Device
- Vibrant System
- Applicant
- Vibrant, Ltd.
- 510(k) number
- K232830
- Product code
- QTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-08
- Date received
- 2023-09-13
- Regulation
- 876.5940
- Classification name
- Orally Ingested Transient Device For Constipation
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Martha Bezalel, Ph.D.
- Address
- Hakochav Pob 516 Yokneam IL 2069206 2069206
FDA Registration Numbers#
- 3011782009
- 3025305436