FDA 510(k) Application Details - K973426

Device Classification Name Electrocardiograph

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510(K) Number K973426
Device Name Electrocardiograph
Applicant D. E. HOKANSON, INC.
12840 N.E. 21ST PL.
BELLEVUE, WA 98005-1910 US
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Contact D. EUGENE HOKANSON
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 09/10/1997
Decision Date 08/12/1998
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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