Device Type ID | 4130 |
Device Name | Endoscope, Ophthalmic |
Regulation Description | Endoscope And Accessories. |
Regulation Medical Specialty | Gastroenterology/Urology |
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 | 510(k) |
CFR Regulation Number | 876.1500 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | KYH |
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 | 4130 |
Device | Endoscope, Ophthalmic |
Product Code | KYH |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Endoscope And Accessories. |
CFR Regulation Number | 876.1500 [🔎] |