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FDA 510(k) Application Details - K100266
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2800
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Classification Product Code
MWJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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