Mucosal Impedance Measurement System
FDA 510(k) clearance K233974 · decided 2024-09-06
Clearance details
- K-number
- K233974
- Device name
- Mucosal Impedance Measurement System
- Applicant
- Alandra Medical Sapi DE CV
- Decision
- Substantially Equivalent
- Date received
- 2023-12-15
- Decision date
- 2024-09-06
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- QIS
- Device class
- 2
- Regulation number
- 876.1450
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mexico City, MX
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alandra Medical Sapi DE CV
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MiVu™ Esophageal Endo Cap (K230056) | Diversatek Healthcare | 2023-04-25 |
| Mucosal Integrity Conductivity (MI) Test System (DEN180067) | Diversatek Healthcare, Inc. | 2019-12-23 |
Recalls involving this device
No recalls on record reference this clearance.