CPR Band

FDA 510(k) K201581 · Credo

Substantially Equivalent

510(k) numberK201581

Submission

Device name
CPR Band
Applicant
Credo
Wonju-Si, KR
Received
June 11, 2020
Decision date
March 6, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LIX – Aid, Cardiopulmonary Resuscitation
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5210
Specialty
Cardiovascular

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 510(k)s with product code LIX

510(k)DeviceApplicantDecision
K183348Reusable Silicone Cover CPRmeter 2LIX · Special Laerdal Medical AS12/17/2018SE
K173886CPRmeter 2 CPR Feedback DeviceLIX · Traditional Laerdal Medical AS03/23/2018SE
K151702Reusable Full Silicone CoverLIX · Special Laerdal Medical AS08/13/2015SE
K123248CPR RSQ AssistLIX · Traditional Avantech, Inc.12/10/2013SE
K123597Truecpr Coaching DeviceLIX · Traditional Physio-Control, Inc.04/17/2013SE
K122050Cprmeter CPR Feedback DeviceLIX · Traditional Laerdal Medical A/S10/22/2012SE
K112660PocketcprLIX · Abbreviated Zoll Medical Corp05/10/2012SE
K092408Rhythm of Life, Model R0901-05LIX · Traditional Rapid Response Solutions, LLC10/14/2009SE
K071321PocketcprLIX · Traditional Bio-Detek, Inc.09/12/2007SE
K010526Modification to the GripLIX · Traditional Elcare Innovations, Inc.12/13/2001SE

Questions and answers

When was CPR Band cleared by the FDA?

CPR Band (K201581) received a 510(k) decision of Substantially Equivalent on March 6, 2021, 268 days after the submission was received.

What is the product code of K201581?

The FDA product code is LIX – Aid, Cardiopulmonary Resuscitation, a Class II (moderate risk) device regulated under 21 CFR 870.5210.