Device Type ID | 2859 |
Device Name | Controller, Closed-loop, Blood-pressure |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | LSX |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2859 |
Device | Controller, Closed-loop, Blood-pressure |
Product Code | LSX |
FDA Device Classification | Class 3 Medical Device |