Home / 510(k) Clearances / K944667

510(k) K944667

LIFE PULSE TESUSCITATION TIMER by Green Field Medical Sourcing, Inc. — Product Code PMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1994
Date Received
September 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cpr Aid Device Without Feedback
Device Class
Class I
Regulation Number
870.5210
Review Panel
CV
Submission Type

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.

Other clearances by Green Field Medical Sourcing, Inc.

  • K971759 — MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER (March 2, 1998)
  • K971348 — FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM (February 27, 1998)
  • K954150 — VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) (December 20, 1995)
  • K932867 — LIFE PULSE RESUSCITATION TIMER (July 25, 1994)

Other clearances for product code PMK

  • K932867 — LIFE PULSE RESUSCITATION TIMER (July 25, 1994)