| Device Type ID | 2644 |
| Device Name | Device, Medical Examination, Ac Powered |
| Regulation Description | AC-powered Medical Examination Light. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.6320 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KZF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2644 |
| Device | Device, Medical Examination, Ac Powered |
| Product Code | KZF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | AC-powered Medical Examination Light. |
| CFR Regulation Number | 880.6320 [🔎] |
| Device Problems | |
|---|---|
Material Separation | 5 |
Detachment Of Device Or Device Component | 3 |
Detachment Of Device Component | 2 |
Device Fell | 2 |
Migration Or Expulsion Of Device | 2 |
Component Missing | 1 |
Device Issue | 1 |
Insufficient Information | 1 |
Mechanical Problem | 1 |
| Total Device Problems | 18 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ohmeda Medical | II | Mar-20-2017 |
| 2 | Stryker Communications | II | Jun-05-2017 |