510(k) K230056
- Device
- MiVu? Esophageal Endo Cap
- Applicant
- Diversatek Healthcare
- 510(k) number
- K230056
- Product code
- QIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-25
- Date received
- 2023-01-09
- Regulation
- 876.1450
- Classification name
- Esophageal, Mucosal, Electrical Characterization
- 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
- Jim Prinster
- Address
- 9150 Commerce Center Cir. Suite 500 Highlands Ranch CO US 80129 80129
FDA Registration Numbers#
- 3009106214
- 2023374