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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 K883297
Device Name HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
Applicant
Hewlett-Packard Co.
175 Wyman St.
Waltham,  MA  02451
Applicant Contact NICHOLAS POLY
Correspondent
Hewlett-Packard Co.
175 Wyman St.
Waltham,  MA  02451
Correspondent Contact NICHOLAS POLY
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/04/1988
Decision Date 10/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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