| Device Type ID | 18 |
| Device Name | Strap, Head, Gas Mask |
| Regulation Description | Gas Mask Head Strap. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.5560 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | BTK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 18 |
| Device | Strap, Head, Gas Mask |
| Product Code | BTK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Gas Mask Head Strap. |
| CFR Regulation Number | 868.5560 [🔎] |
| Device Problems | |
|---|---|
Biocompatibility | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 3 |