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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
510(k) Number K812167
Device Name MODEL 78850 OXYGEN MONITOR
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 Number868.2500
Classification Product Code
KLK  
Date Received07/30/1981
Decision Date 08/31/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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