Device Type ID | 4207 |
Device Name | Chair, Ophthalmic, Ac-powered |
Regulation Description | Ophthalmic Chair. |
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 | 886.1140 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HME |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4207 |
Device | Chair, Ophthalmic, Ac-powered |
Product Code | HME |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Ophthalmic Chair. |
CFR Regulation Number | 886.1140 [🔎] |
Device Problems | |
---|---|
Positioning Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Use Of Device Problem | 1 |
Total Device Problems | 3 |