| Device Type ID | 852 |
| Device Name | Analyzer, Pacemaker Generator Function, Indirect |
| Regulation Description | Indirect Pacemaker Generator Function Analyzer. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Implantable Electrophysical Devices Branch (IEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3640 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KRE |
| 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 | 852 |
| Device | Analyzer, Pacemaker Generator Function, Indirect |
| Product Code | KRE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Indirect Pacemaker Generator Function Analyzer. |
| CFR Regulation Number | 870.3640 [🔎] |
| Device Problems | |
|---|---|
Data Problem | 9 |
Communication Or Transmission Problem | 2 |
Date/Time-Related Software Problem | 1 |
Display Difficult To Read | 1 |
Appropriate Term/Code Not Available | 1 |
Display Or Visual Feedback Problem | 1 |
| Total Device Problems | 15 |