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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K903523
Device Name HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE
Applicant
HEWLETT-PACKARD CO.
SCHUCKARDSTRABE 4
7030 BOBLINGEN
GERMANY,  DE
Applicant Contact GERHARD LENKE
Correspondent
HEWLETT-PACKARD CO.
SCHUCKARDSTRABE 4
7030 BOBLINGEN
GERMANY,  DE
Correspondent Contact GERHARD LENKE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/06/1990
Decision Date 10/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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