| Device Type ID | 4148 |
| Device Name | Lens, Fundus, Hruby, Diagnostic |
| Regulation Description | Diagnostic Hruby Fundus Lens. |
| 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 | 886.1395 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HJI |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4148 |
| Device | Lens, Fundus, Hruby, Diagnostic |
| Product Code | HJI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Diagnostic Hruby Fundus Lens. |
| CFR Regulation Number | 886.1395 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Volk Optical Inc | III | Jul-09-2015 |