| Device Type ID | 1955 |
| Device Name | Monitor, Esophageal Motility, And Tube |
| Regulation Description | Gastrointestinal Motility Monitoring System. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KLA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1955 |
| Device | Monitor, Esophageal Motility, And Tube |
| Product Code | KLA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Motility Monitoring System. |
| CFR Regulation Number | 876.1725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDSPIRA, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THD SPA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |