FDA 510(k) Application Details - K951128

Device Classification Name Electrocardiograph

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510(K) Number K951128
Device Name Electrocardiograph
Applicant OXFORD MEDICAL, INC.
11526 53RD ST. NORTH
CLEARWATER, FL 34620 US
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Contact CHARLES HOLZ
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 03/13/1995
Decision Date 08/28/1996
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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