PMK — Cpr Aid Device Without Feedback Class I
FDA product code PMK covers "Cpr Aid Device Without Feedback", a Class I medical device regulated under 21 CFR 870.5210. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PMK
- Device Class
- Class I
- Regulation Number
- 870.5210
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.