FDA 510(k) Application Details - K050074

Device Classification Name Electrocardiograph

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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
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Contact CHRISTOPHER KLACZYKN
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Regulation Number 870.2340

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Classification Product Code DPS
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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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