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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 K843643
Device Name COLOR DOPPLER 880
Applicant
Irex Corp.
69 Spring St.
Ramsey,  NJ  07446
Applicant Contact RAYMOND F CHASE
Correspondent
Irex Corp.
69 Spring St.
Ramsey,  NJ  07446
Correspondent Contact RAYMOND F CHASE
Regulation Number870.2330
Classification Product Code
DXK  
Date Received09/17/1984
Decision Date 01/31/1985
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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