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FDA 510(k) Application Details - K050951
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K050951
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
CIBERNET SYSTEMS CORP.
727 AIRPORT BOULEVARD
ANN ARBOR, MI 48108 US
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Contact
ERIC LICHTENSTEIN
Other 510(k) Applications for this Contact
Regulation Number
870.2920
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Classification Product Code
DXH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/15/2005
Decision Date
07/19/2005
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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