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FDA 510(k) Application Details - K010945
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K010945
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
INSTROMEDIX
6779 MESA RIDGE RD., SUITE 200
SAN DIEGO, CA 92121-2909 US
Other 510(k) Applications for this Company
Contact
ALDEN KAY
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
03/29/2001
Decision Date
06/12/2001
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
N
Expedited Review
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