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FDA 510(k) Application Details - K060297
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K060297
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
MEDICAL MONITORS LTD
SUITE 407 OFFICE TOWER
WESTFIELD EAST GARDENS NSW 2036 AU
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Contact
RICHARD HYMAN
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
02/06/2006
Decision Date
08/02/2006
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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