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FDA 510(k) Application Details - K111601
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K111601
Device Name
Electrocardiograph
Applicant
MEDICAL PREDICTIVE SCIENCE CORP.
2246 IVY RD., SUITE 17
CHARLOTTESVILLE, VA 22903 US
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Contact
WILL KING
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/08/2011
Decision Date
07/08/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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