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FDA 510(k) Application Details - K003520
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
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510(K) Number
K003520
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
NEXAN LTD
1801 ROCKVILLE PIKE
SUITE 300
ROCKVILLE, MD 20852 US
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Contact
DAVID L WEST
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Regulation Number
870.2800
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Classification Product Code
MWJ
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More FDA Info for this Product Code
Date Received
11/15/2000
Decision Date
12/13/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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