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FDA 510(k) Application Details - K020366
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K020366
Device Name
Electrocardiograph
Applicant
CARDIOCOMM SOLUTIONS, INC.
3060 CEDAR HILL RD., SUITE 201
VICTORIA, B.C. V8T 3J5 CA
Other 510(k) Applications for this Company
Contact
ANGELA HALWAS
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/04/2002
Decision Date
04/30/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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