510(k) K842497

SERVOMED OXYMONITO SMK 363 by Litton Datamedix — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1984
Date Received
June 26, 1984
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