FDA 510(k) Application Details - K983626

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

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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
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Regulation Number 870.2920

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Classification Product Code DXH
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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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