510(k) DEN180067
DEN180067 is an FDA 510(k) premarket notification submitted by Diversatek Healthcare, Inc. for the device "Mucosal Integrity Conductivity (MI) Test System". The FDA issued a decision of De Novo Granted on December 23, 2019. The device falls under product code QIS (Esophageal, Mucosal, Electrical Characterization), a Class II device regulated under 21 CFR 876.1450. Diversatek Healthcare, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 23, 2019
- Date Received
- December 17, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esophageal, Mucosal, Electrical Characterization
- Device Class
- Class II
- Regulation Number
- 876.1450
- Review Panel
- GU
- Submission Type
The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.