Mucosal Integrity Conductivity (MI) Test System
FDA 510(k) clearance DEN180067 · decided 2019-12-23
Clearance details
- K-number
- DEN180067
- Device name
- Mucosal Integrity Conductivity (MI) Test System
- Applicant
- Diversatek Healthcare, Inc.
- Decision
- Unknown
- Date received
- 2018-12-17
- Decision date
- 2019-12-23
- Days to decision
- 371 days
- Clearance type
- Direct
- Product code
- QIS
- Device class
- 2
- Regulation number
- 876.1450
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Highlands Ranch, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Mucosal Impedance Measurement System (K233974) | Alandra Medical Sapi DE CV | 2024-09-06 |
| MiVu™ Esophageal Endo Cap (K230056) | Diversatek Healthcare | 2023-04-25 |
Recalls involving this device
No recalls on record reference this clearance.