Device Type ID | 4219 |
Device Name | Keratome, Battery-powered |
Regulation Description | Keratome. |
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 | 886.4370 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HMY |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 4219 |
Device | Keratome, Battery-powered |
Product Code | HMY |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Keratome. |
CFR Regulation Number | 886.4370 [🔎] |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
Total Device Problems | 1 |