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FDA 510(k) Application Details - K983626
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K983626
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
ALARIS MEDICAL SYSTEMS, INC.
7431 N.W. EVERGREEN PKWY.
ONE TECHNOLOGY CENTER
HILLSBORO, OR 97124-5898 US
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Contact
GARY N MILLS
Other 510(k) Applications for this Contact
Regulation Number
870.2920
More FDA Info for this Regulation Number
Classification Product Code
DXH
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More FDA Info for this Product Code
Date Received
10/15/1998
Decision Date
02/05/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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