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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 K093172
Device Name QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)
Applicant
Dynacardia, Inc.
1330 Mountain View Cir.
Azusa,  CA  91702
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/08/2009
Decision Date 01/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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