| Device Type ID | 4208 |
| Device Name | Stand, Instrument, Ac-powered, Ophthalmic |
| Regulation Description | Ophthalmic Instrument Stand. |
| Regulation Medical Specialty | Ophthalmic |
| 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) Exempt |
| CFR Regulation Number | 886.1860 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HMF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4208 |
| Device | Stand, Instrument, Ac-powered, Ophthalmic |
| Product Code | HMF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Ophthalmic Instrument Stand. |
| CFR Regulation Number | 886.1860 [🔎] |
| Device Problems | |
|---|---|
Component Falling | 1 |
Break | 1 |
Device Slipped | 1 |
Device Operates Differently Than Expected | 1 |
Device Dislodged Or Dislocated | 1 |
| Total Device Problems | 5 |