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FDA 510(k) Application Details - K180242
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K180242
Device Name
Electrocardiograph
Applicant
Medical Predictive Science Corporation
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
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Classification Product Code
DPS
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More FDA Info for this Product Code
Date Received
01/29/2018
Decision Date
02/28/2018
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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