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510(k) K201581

Device
CPR BAND
Applicant
CREDO
510(k) number
K201581
Product code
LIX  
Decision
Substantially Equivalent (SESE)
Decision date
2021-03-06
Date received
2020-06-11
Regulation
870.5210
Classification name
Aid, Cardiopulmonary Resuscitation
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ji Hyo Wang
Address
#302, 86, Baeul-Ro Wonju-Si KR 26465 26465

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LIX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K183348Reusable Silicone Cover CPRmeter 2Laerdal Medical AS2018-12-17
K173886CPRmeter 2 CPR Feedback DeviceLaerdal Medical AS2018-03-23
K151702Reusable Full Silicone CoverLaerdal Medical AS2015-08-13
K123248CPR RSQ ASSISTAvantech, Inc.2013-12-10
K123597TRUECPR COACHING DEVICEPhysio-Control, Inc.2013-04-17
K122050CPRMETER CPR FEEDBACK DEVICELaerdal Medical A/S2012-10-22
K112660POCKETCPRZoll Medical Corp2012-05-10
K092408RHYTHM OF LIFE, MODEL R0901-05Rapid Response Solutions, LLC2009-10-14
K071321POCKETCPRBio-Detek, Inc.2007-09-12
K010526MODIFICATION TO THE GRIPElcare Innovations, Inc.2001-12-13
K003937CPR EZY MASK AND PADMedteq Innovations Pty, Ltd.2001-06-06
K954692CPR PROMPTCounty Line , Ltd.1996-03-27
K926333CPR PLUSKells Medical, Inc.1993-11-08
K900415C.P.R. LANDMARCCan-Am Medical, Inc.1990-06-12
K843977PULSE-AID DEVICEJames J. Lally1985-02-01

Legacy Summary#

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FDA Review#

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