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Cpr Aid Device Without Feedback

FDA product code PMK · 2 cleared devices

Class 1 Cardiovascular
Regulation
21 CFR 870.5210
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1994-07-25 – 1994-10-04

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.

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