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510(k) K201581

CPR BAND by Credo — Product Code LIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2021
Date Received
June 11, 2020
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

  • 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)
  • K010526 — MODIFICATION TO THE GRIP (December 13, 2001)