| Device Type ID | 860 |
| Device Name | Dc-defibrillator, Low-energy, (including Paddles) |
| Regulation Description | DC-defibrillator (including Paddles). |
| 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 | 870.5300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LDD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 860 |
| Device | Dc-defibrillator, Low-energy, (including Paddles) |
| Product Code | LDD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | DC-defibrillator (including Paddles). |
| CFR Regulation Number | 870.5300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FULL POWER AED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZOLL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Discharge | 25 |
Device Displays Incorrect Message | 7 |
Failure To Deliver Shock | 6 |
Fitting Problem | 6 |
Failure To Deliver Energy | 6 |
Energy Output Problem | 5 |
Device Operates Differently Than Expected | 5 |
Connection Problem | 4 |
Device Inoperable | 3 |
Defibrillation Problem | 3 |
Loose Or Intermittent Connection | 2 |
Unable To Obtain Readings | 2 |
Output Problem | 2 |
Device Operational Issue | 2 |
Intermittent Continuity | 2 |
Electrical /Electronic Property Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Output Below Specifications | 1 |
Signal Artifact | 1 |
No Display / Image | 1 |
Intermittent Shock | 1 |
Cable | 1 |
Defibrillator Paddles | 1 |
Failure To Sense | 1 |
Defective Component | 1 |
Failure To Capture | 1 |
Noise, Audible | 1 |
Break | 1 |
Failure To Conduct | 1 |
Monitor Failure | 1 |
Pacing Problem | 1 |
Failure To Power Up | 1 |
Computer Operating System Problem | 1 |
Failure Of Device To Self-Test | 1 |
Improper Alarm | 1 |
| Total Device Problems | 101 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ConMed Corporation | I | Dec-04-2014 |