PMK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Cpr Aid Device Without Feedback
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.5210
- Medical specialty
- Cardiovascular
- FDA definition
- A device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIFE PULSE TESUSCITATION TIMER (K944667) | Green Field Medical Sourcing, Inc. | 1994-10-04 |
| LIFE PULSE RESUSCITATION TIMER (K932867) | Green Field Medical Sourcing, Inc. | 1994-07-25 |
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Every clearance here is in the API, with alerts when new ones post.