FDA 510(k) Application Details - K100266

Device Classification Name Electrocardiograph,Ambulatory(Without Analysis)

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510(K) Number K100266
Device Name Electrocardiograph,Ambulatory(Without Analysis)
Applicant CAMNTECH, LTD
UPPER PENDRILL COURT
PAPWORTH EVERARD, CAMBRIDGESHI CB233UY GB
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Contact HOWARD SMITH
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Regulation Number 870.2800

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Classification Product Code MWJ
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Date Received 01/29/2010
Decision Date 04/29/2010
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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