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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 K881136
Device Name HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
Applicant
HEWLETT-PACKARD CO.
175 WALTHAM ST.
P.O.BOX 9030
WALTHAM,  MA  02254
Applicant Contact NICHOLAS POLY
Correspondent
HEWLETT-PACKARD CO.
175 WALTHAM ST.
P.O.BOX 9030
WALTHAM,  MA  02254
Correspondent Contact NICHOLAS POLY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/16/1988
Decision Date 05/18/1988
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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