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510(k) K122050

CPRMETER CPR FEEDBACK DEVICE by Laerdal Medical A/S — Product Code LIX

K122050 is an FDA 510(k) premarket notification submitted by Laerdal Medical A/S for the device "CPRMETER CPR FEEDBACK DEVICE". The FDA issued a decision of Substantially Equivalent on October 22, 2012. The device falls under product code LIX (Aid, Cardiopulmonary Resuscitation), a Class II device regulated under 21 CFR 870.5210. Laerdal Medical A/S has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2012
Date Received
July 12, 2012
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 by Laerdal Medical A/S

  • K251631 — The BAG manual resuscitator and accessories (November 24, 2025)
  • K232111 — NeoBeat, NeoBeat Mini (June 25, 2024)
  • 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)
  • K132172 — NEONATALIE RESUSCITATOR (January 15, 2015)
  • 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)
  • 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)
  • 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)

FDA data resources