Home / 510(k) Clearances / K954692

510(k) K954692

CPR PROMPT by County Line , Ltd. — Product Code LIX

K954692 is an FDA 510(k) premarket notification submitted by County Line , Ltd. for the device "CPR PROMPT". The FDA issued a decision of Substantially Equivalent on March 27, 1996. The device falls under product code LIX (Aid, Cardiopulmonary Resuscitation), a Class II device regulated under 21 CFR 870.5210.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1996
Date Received
October 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aid, Cardiopulmonary Resuscitation
Device Class
Class II
Regulation Number
870.5210
Review Panel
CV
Submission Type

CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software

Other clearances for product code LIX

  • K201581 — CPR BAND (March 6, 2021)
  • K183348 — Reusable Silicone Cover CPRmeter 2 (December 17, 2018)
  • K173886 — CPRmeter 2 CPR Feedback Device (March 23, 2018)
  • K151702 — Reusable Full Silicone Cover (August 13, 2015)
  • K123248 — CPR RSQ ASSIST (December 10, 2013)
  • K123597 — TRUECPR COACHING DEVICE (April 17, 2013)
  • K122050 — CPRMETER CPR FEEDBACK DEVICE (October 22, 2012)
  • K112660 — POCKETCPR (May 10, 2012)
  • K092408 — RHYTHM OF LIFE, MODEL R0901-05 (October 14, 2009)
  • K071321 — POCKETCPR (September 12, 2007)

FDA data resources