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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph
510(k) Number K152135
Device Name Quantitative Electrocardiographic Detector (QED 2000)
Applicant
ACME Portable Machines, Inc.
1330 Mountain View Circle
azusa,  CA  91702
Applicant Contact james cheng
Correspondent
ACME Portable Machines, Inc.
1330 Mountain View Circle
azusa,  CA  91702
Correspondent Contact james cheng
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/31/2015
Decision Date 08/09/2016
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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