Device Type ID | 4433 |
Device Name | Medical Computers And Software For Ophthalmic Use |
Review Panel | Ophthalmic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
Submission Type | Contact ODE |
FDA Device Classification | Class 3 Medical Device |
Product Code | LQB |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4433 |
Device | Medical Computers And Software For Ophthalmic Use |
Product Code | LQB |
FDA Device Classification | Class 3 Medical Device |