510(k) K832652

OXY MONITOR 5-RANGE DUAL-THERMISTOR by Litton Medical Electronics — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1983
Date Received
August 8, 1983
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