Device Type ID | 825 |
Device Name | Ballistocardiograph |
Regulation Description | Ballistocardiograph. |
Regulation Medical Specialty | Cardiovascular |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
Submission Type | 510(k) |
CFR Regulation Number | 870.2320 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | DXR |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 825 |
Device | Ballistocardiograph |
Product Code | DXR |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Ballistocardiograph. |
CFR Regulation Number | 870.2320 [🔎] |