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FDA 510(k) Application Details - K040942
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K040942
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
BIOWATCH MEDICAL, INC.
1233 WASHINGTON STREET
SUITE 400
COLUMBIA, SC 29201-3221 US
Other 510(k) Applications for this Company
Contact
URSULA E WILSON
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
04/12/2004
Decision Date
09/15/2004
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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