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FDA 510(k) Application Details - K012264
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K012264
Device Name
Electrocardiograph
Applicant
NATIONAL CUSTOM ENT., INC.
1133 EAST CLIFF RD.
BURNSVILLE, MN 55337 US
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Contact
DON PELLETIER
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
07/18/2001
Decision Date
10/10/2001
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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