Isocapnic Ventilation Device
Device Code: 219
Product Code(s):
QFB Definition: An Isocapnic Ventilation Device Is A Prescription Device Used To Administer A Blend Of Carbon Dioxide And Oxygen Gases To A Patient To Induce Hyperventilation. This Device May Be Labeled For Use With Breathing Circuits Made Of Reservoir Bags (21 CFR
Device Classification Information
| Device Type ID | 219 |
| Device Name | Isocapnic Ventilation Device |
| Physical State | Device Controls Gas Concentration, Flowrate, And Output Pressures. Gases Are Delivered Via Breathing Circuits. |
| Technical Method | Device Administers Blend Of Oxygen And Carbon Dioxide Via A Patient Breathing Circuit To Enable Isocapnic Breathing. |
| Target Area | Lungs |
| Regulation Medical Specialty | General Hospital |
| Review Panel | Anesthesiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5480 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QFB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 219 |
| Device | Isocapnic Ventilation Device |
| Product Code | QFB |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 868.5480 [🔎] |
TPLC Last Update: 2019-04-02 19:30:50