PMK · Class I · 21 CFR 870.5210

FDA Product Code PMK: Cpr Aid Device Without Feedback

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.

Leading manufacturers include Green Field Medical Sourcing, Inc..

2
Total
2
Cleared
210d
Avg days
1994
Since

FDA 510(k) Cleared Cpr Aid Device Without Feedback Devices (Product Code PMK)

2 devices
1–2 of 2
Cleared Oct 04, 1994
LIFE PULSE TESUSCITATION TIMER
K944667
Green Field Medical Sourcing, Inc.
Anesthesiology · 14d
Cleared Jul 25, 1994
LIFE PULSE RESUSCITATION TIMER
K932867
Green Field Medical Sourcing, Inc.
Anesthesiology · 406d

About Product Code PMK - Regulatory Context