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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocardiograph, ambulatory (without analysis)
510(k) Number K001317
Device Name ARIA
Applicant
DEL MAR MEDICAL SYSTEMS, LLC.
1621 ALTON PKWY.
IRVINE,  CA  92606
Applicant Contact ED CRESPIN
Correspondent
DEL MAR MEDICAL SYSTEMS, LLC.
1621 ALTON PKWY.
IRVINE,  CA  92606
Correspondent Contact ED CRESPIN
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received04/26/2000
Decision Date 07/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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