Device Type ID | 2581 |
Device Name | Bottle, Hot/cold Water |
Regulation Description | Hot/cold Water Bottle. |
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 | 880.6085 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | FPF |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2581 |
Device | Bottle, Hot/cold Water |
Product Code | FPF |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Hot/cold Water Bottle. |
CFR Regulation Number | 880.6085 [🔎] |
Device Problems | |
---|---|
Leak / Splash | 1 |
Fluid Leak | 1 |
Total Device Problems | 2 |