| Device Type ID | 818 |
| Device Name | Echocardiograph |
| Regulation Description | Echocardiograph. |
| 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 | 870.2330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 818 |
| Device | Echocardiograph |
| Product Code | DXK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Echocardiograph. |
| CFR Regulation Number | 870.2330 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 2 |
Tip | 2 |
Catheter | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Device Packaging Compromised | 1 |
Break | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 11 |