QOP — Respiratory Humidifier For Emergency Use Class N
FDA product code QOP covers "Respiratory Humidifier For Emergency Use", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QOP
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Unknown
- Implant
- No
Definition
Intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device for use during declared public health emergency.