Device Type ID | 4361 |
Device Name | Device, Analysis, Anterior Segment |
Regulation Description | AC-powered Slitlamp Biomicroscope. |
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) |
CFR Regulation Number | 886.1850 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MXK |
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 | 4361 |
Device | Device, Analysis, Anterior Segment |
Product Code | MXK |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | AC-powered Slitlamp Biomicroscope. |
CFR Regulation Number | 886.1850 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
OCULUS OPTIKGERATE GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SANTEC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Oculus Optikgeraete GMBH | II | Feb-16-2018 |