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FDA 510(k) Application Details - K051686
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
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510(K) Number
K051686
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG
55 Northern Blvd
Suite 200
Great Neck, NY 11021 US
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Contact
CAROLANN KOTULA
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Regulation Number
870.2800
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Classification Product Code
MWJ
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More FDA Info for this Product Code
Date Received
06/23/2005
Decision Date
07/14/2005
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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