510(k) K183348

Reusable Silicone Cover CPRmeter 2 by Laerdal Medical AS — Product Code LIX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 17, 2018
Date Received: December 3, 2018
Clearance Type: Special
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 by Laerdal Medical AS

K251631 — The BAG manual resuscitator and accessories (November 24, 2025)
K232111 — NeoBeat, NeoBeat Mini (June 25, 2024)
K173886 — CPRmeter 2 CPR Feedback Device (March 23, 2018)
K151702 — Reusable Full Silicone Cover (August 13, 2015)
K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
K122050 — CPRMETER CPR FEEDBACK DEVICE (October 22, 2012)
K023805 — LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 (February 11, 2003)
K001742 — RESUSCI INFLATE-A-SHIELD CPR BARRIER (October 6, 2000)
K993668 — LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 (December 20, 1999)
K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (September 5, 1996)

Other clearances for product code LIX

K201581 — CPR BAND (March 6, 2021)
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)
K010526 — MODIFICATION TO THE GRIP (December 13, 2001)