| Device Type ID | 815 |
| Device Name | Computer, Diagnostic, Pre-programmed, Single-function |
| Regulation Description | Single-function, Preprogrammed Diagnostic Computer. |
| 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 | 870.1435 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXG |
| 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 | 815 |
| Device | Computer, Diagnostic, Pre-programmed, Single-function |
| Product Code | DXG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Single-function, Preprogrammed Diagnostic Computer. |
| CFR Regulation Number | 870.1435 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOMED INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EDWARDS LIFESCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GE HEALTHCARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GENERAL ELECTRIC CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIDCO LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PULSION MEDICAL SYSTEMS SE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRANSONIC SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 80 |
Incorrect Measurement | 56 |
Smoking | 11 |
Fire | 5 |
Thermal Decomposition Of Device | 3 |
Sparking | 2 |
Use Of Device Problem | 2 |
Capturing Problem | 1 |
Melted | 1 |
Electrical /Electronic Property Problem | 1 |
High Test Results | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Device Operates Differently Than Expected | 1 |
Inflation Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Improper Device Output | 1 |
Data Problem | 1 |
Display Or Visual Feedback Problem | 1 |
Positioning Failure | 1 |
Device Issue | 1 |
| Total Device Problems | 172 |