Device Type ID | 2605 |
Device Name | Scale, Patient |
Regulation Description | Patient Scale. |
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 | 880.2720 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FRW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2605 |
Device | Scale, Patient |
Product Code | FRW |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Patient Scale. |
CFR Regulation Number | 880.2720 [🔎] |
Device Problems | |
---|---|
Overheating Of Device | 2 |
Calibration Problem | 1 |
Loose Or Intermittent Connection | 1 |
Device Maintenance Issue | 1 |
Unintended Movement | 1 |
Device Emits Odor | 1 |
Device Inoperable | 1 |
Material Integrity Problem | 1 |
Device Operational Issue | 1 |
Electrical /Electronic Property Problem | 1 |
No Display / Image | 1 |
Melted | 1 |
Total Device Problems | 13 |