Definition: To Measure The Temperature Of Exhaled Human Breath, Which Is Frequently Increased In Airway Inflammation In Asthma Patients. Measurement Of Changes In Exhaled Human Breath Temperature Aids In Evaluating Airway Inflammation Treatment In Asthma Patient
| Device Type ID | 2735 |
| Device Name | Thermometer, Exhaled Breath |
| Physical State | The Major Components Of The Device Are: A. A 0.5-litre Silver Plated Flask In A Metal Cylinder (thermos) B. An Air Tube And Thermal Block Made Out Of Copper With An In-built Temperature Sensor. The Thermal Block Has A Tube-like Part With High Thermal |
| Technical Method | The Essence Of The Device Technology Is An Environmental Chamber With A Thermal Core Heated By Exhaled Air From The Patient. Each Exhalation Increases The Temperature Inside The Reservoir Until Equilibrium Is Reached And Measured By A Thermal Sensor. |
| Target Area | Mouth |
| Regulation Description | Clinical Electronic Thermometer. |
| 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) |
| CFR Regulation Number | 880.2910 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OZK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2735 |
| Device | Thermometer, Exhaled Breath |
| Product Code | OZK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Clinical Electronic Thermometer. |
| CFR Regulation Number | 880.2910 [🔎] |