Device Type ID | 1687 |
Device Name | Pill, Radio |
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 | EXW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1687 |
Device | Pill, Radio |
Product Code | EXW |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Gastrointestinal Motility Monitoring System. |
CFR Regulation Number | 876.1725 [🔎] |