Device Type ID | 5 |
Device Name | Absorber, Carbon-dioxide |
Regulation Description | Carbon Dioxide Absorber. |
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 | 868.5310 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | BSF |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5 |
Device | Absorber, Carbon-dioxide |
Product Code | BSF |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Carbon Dioxide Absorber. |
CFR Regulation Number | 868.5310 [🔎] |
Device Problems | |
---|---|
Insufficient Information | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Total Device Problems | 2 |