inforMED
PMKClass I

Cpr Aid Device Without Feedback

Cardiovascular · 21 CFR 870.5210

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.

MDR events0All time
Recalls0All time
Registered firms10Currently listed
510(k) clearances2All time

Recent MDR events

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No MDR events on file for this product code.

Event type breakdown

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Recalls

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No recalls on file for this product code.