Device Type ID | 2011 |
Device Name | System, Electrogastrography (egg) |
Regulation Description | Electrogastrography System. |
Regulation Medical Specialty | Gastroenterology/Urology |
Review Panel | Gastroenterology/Urology |
Premarket Review | Center For Biologics Evaluation & Research (CBER) |
Submission Type | 510(k) |
CFR Regulation Number | 876.1735 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MYE |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2011 |
Device | System, Electrogastrography (egg) |
Product Code | MYE |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Electrogastrography System. |
CFR Regulation Number | 876.1735 [🔎] |