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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 K003520
Device Name NEXAN SYSTEM, MODEL NX-300
Applicant
NEXAN LTD
1801 ROCKVILLE PIKE
SUITE 300
ROCKVILLE,  MD  20852
Applicant Contact DAVID L WEST
Correspondent
NEXAN LTD
1801 ROCKVILLE PIKE
SUITE 300
ROCKVILLE,  MD  20852
Correspondent Contact DAVID L WEST
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received11/15/2000
Decision Date 12/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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