Definition: A Closed-loop Autotitration Device For Intraoral Appliances Uses A Feedback Control To Record Changes In The Patient’s Respiratory Status Related To Repositioning Of The Mandible During An Overnight Study. The Data Are Analyzed By A Healthcare Provid
| Device Type ID | 1390 |
| Device Name | Closed Loop Auto Titration Device For Oral Appliances |
| Physical State | Temporary Intraoral Mouthpiece Attached To Recorders And Sensors To Monitor Physiologic Responses To Airflow And Oxygen Desaturation During Sleep. |
| Technical Method | Device Functions As A Closed Loop Auto Titration Device. |
| Target Area | Oral Cavity. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.5571 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QCJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1390 |
| Device | Closed Loop Auto Titration Device For Oral Appliances |
| Product Code | QCJ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 872.5571 [🔎] |