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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Echocardiograph
510(k) Number K802670
Device Name CONTIUOUS WAVE DOPPLER ULTRASOUND
Applicant
American Edwards Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Edwards Laboratories
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.2330
Classification Product Code
DXK  
Date Received10/27/1980
Decision Date 11/26/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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