Device Type ID | 140 |
Device Name | Mask, Scavenging |
Regulation Description | Scavenging Mask. |
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 | 868.5590 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | KHA |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 140 |
Device | Mask, Scavenging |
Product Code | KHA |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Scavenging Mask. |
CFR Regulation Number | 868.5590 [🔎] |