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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K833913
Device Name HEMODYNAMIC PLUG-IN MODULE 78551A
Applicant
HEWLETT-PACKARD CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HEWLETT-PACKARD CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.1435
Classification Product Code
DXG  
Date Received11/14/1983
Decision Date 03/22/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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