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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K903771
Device Name HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
Applicant
Hewlett-Packard Co.
Werk Boblingen
Herrenberger Strabe 110-130
7030 Boblingen,  DE
Applicant Contact GERHARD LENKE
Correspondent
Hewlett-Packard Co.
Werk Boblingen
Herrenberger Strabe 110-130
7030 Boblingen,  DE
Correspondent Contact GERHARD LENKE
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/20/1990
Decision Date 02/19/1991
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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