Device Type ID | 73 |
Device Name | Cart, Emergency, Cardiopulmonary (excluding Equipment) |
Regulation Description | Cardiopulmonary Emergency Cart. |
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) Respiratory Devices Branch (RPDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 868.6175 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | BZN |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 73 |
Device | Cart, Emergency, Cardiopulmonary (excluding Equipment) |
Product Code | BZN |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Cardiopulmonary Emergency Cart. |
CFR Regulation Number | 868.6175 [🔎] |
Device Problems | |
---|---|
Break | 2 |
Sparking | 2 |
Device Inoperable | 1 |
Electrical /Electronic Property Problem | 1 |
Connection Problem | 1 |
Insufficient Information | 1 |
Wheel | 1 |
Total Device Problems | 9 |