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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plethysmograph, impedance
510(k) Number K191697
Device Name Cardiac Monitor 1500
Applicant
Zynex Medical, Inc.
9995 Maroon Circle
englewood,  CO  80112
Applicant Contact thomas sandgaard
Correspondent
Zynex Medical, Inc.
9995 Maroon Circle
englewood,  CO  80112
Correspondent Contact thomas sandgaard
Regulation Number870.2770
Classification Product Code
DSB  
Subsequent Product Codes
DQA   FLL  
Date Received06/25/2019
Decision Date 02/21/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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