Device Type ID | 820 |
Device Name | Densitometer |
Regulation Description | Densitometer. |
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 | 870.1450 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | DXM |
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 | 820 |
Device | Densitometer |
Product Code | DXM |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Densitometer. |
CFR Regulation Number | 870.1450 [🔎] |