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FDA 510(k) Application Details - K982843
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
More FDA Info for this Device
510(K) Number
K982843
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
INDUSTRIAL TECHNOLOGY RESEARCH INSTITUTE
BLDG 16, 321 KUANG FU RD,SEC 2
HSINCHU TW
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Contact
MING-CHENG CHANG
Other 510(k) Applications for this Contact
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
08/12/1998
Decision Date
11/10/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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