510(k) DEN180067
- Device
- Mucosal Integrity Conductivity (MI) Test System
- Applicant
- Diversatek Healthcare, Inc.
- 510(k) number
- DEN180067
- Product code
- QIS
- Decision
- Unknown (DENG)
- Decision date
- 2019-12-23
- Date received
- 2018-12-17
- Regulation
- 876.1450
- Classification name
- Esophageal, Mucosal, Electrical Characterization
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Laura L Boll
- Address
- 9150 Commerce Center Cir. Suite 500 Highlands Ranch CO US 80129 80129
FDA Registration Numbers#
- 2023374
- 3009106214
Source Documents#
510(k) summary PDF not indicated by FDA