510(k) K925910

HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE by Hewlett-Packard Co. — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1993
Date Received
November 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class
Class II
Regulation Number
868.2500
Review Panel
AN
Submission Type