PMK — Cpr Aid Device Without Feedback Class I

FDA Device Classification

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K944667green field medical sourcingLIFE PULSE TESUSCITATION TIMEROctober 4, 1994
K932867green field medical sourcingLIFE PULSE RESUSCITATION TIMERJuly 25, 1994