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FDA 510(k) Application Details - K141813
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K141813
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
RHYTHMEDIX, LLC
5353 WAYZATA BLVD, SUITE 505
MINNEAPOLIS, MN 55416 US
Other 510(k) Applications for this Company
Contact
M.W.(ANDY) ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
870.2920
More FDA Info for this Regulation Number
Classification Product Code
DXH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/07/2014
Decision Date
08/05/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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