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FDA 510(k) Application Details - K951096
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
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510(K) Number
K951096
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
INSTROMEDIX, INC.
ONE TECHNOLOGY CENTER
7431 N.E. EVERGREEN PARKWAY
HILLSBORO, OR 97124-5898 US
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HERBERT J SEMLER
Other 510(k) Applications for this Contact
Regulation Number
870.2920
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Classification Product Code
DXH
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More FDA Info for this Product Code
Date Received
03/07/1995
Decision Date
01/16/1996
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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