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FDA 510(k) Application Details - K050074
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K050074
Device Name
Electrocardiograph
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY 13153-0220 US
Other 510(k) Applications for this Company
Contact
CHRISTOPHER KLACZYKN
Other 510(k) Applications for this Contact
Regulation Number
870.2340
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Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/12/2005
Decision Date
03/22/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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