Device Type ID | 763 |
Device Name | Oscillometer |
Regulation Description | Oscillometer. |
Regulation Medical Specialty | Cardiovascular |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 870.2675 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | DRZ |
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 | 763 |
Device | Oscillometer |
Product Code | DRZ |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Oscillometer. |
CFR Regulation Number | 870.2675 [🔎] |