Definition: CPR Aid Device WITH Feedback (visual, Audio Or Both) On One Or More CPR Parameters (e.g., Rate, Depth, Ventilation Ratio, Etc.), And Contains Software. Provides Real-time Feedback On CPR Performance. Feedback Can Be Audio, Visual Or Both. Device Cont
| Device Type ID | 864 |
| Device Name | Aid, Cardiopulmonary Resuscitation |
| Regulation Description | Cardiopulmonary Resuscitation (CPR) Aid. |
| 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) |
| CFR Regulation Number | 870.5210 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LIX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 864 |
| Device | Aid, Cardiopulmonary Resuscitation |
| Product Code | LIX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Resuscitation (CPR) Aid. |
| CFR Regulation Number | 870.5210 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LAERDAL MEDICAL AS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
LAERDAL MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Philips Electronics North America Corporation | II | Feb-22-2018 |