Device Type ID | 5460 |
Device Name | Device, Telemedicine, Robotic |
Regulation Description | Endoscope And Accessories. |
Regulation Medical Specialty | Gastroenterology/Urology |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
Submission Type | 510(k) |
CFR Regulation Number | 876.1500 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NEQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5460 |
Device | Device, Telemedicine, Robotic |
Product Code | NEQ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Endoscope And Accessories. |
CFR Regulation Number | 876.1500 [🔎] |