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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 K925910
Device Name HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
Applicant
Hewlett-Packard Co.
Schuckardstrabe 4
7030 Boblingen
Germany,  DE
Applicant Contact VAN DYK
Correspondent
Hewlett-Packard Co.
Schuckardstrabe 4
7030 Boblingen
Germany,  DE
Correspondent Contact VAN DYK
Regulation Number868.2500
Classification Product Code
KLK  
Date Received11/23/1992
Decision Date 07/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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