510(k) K870805

MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR by Novametrix Medical Systems, Inc. — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1987
Date Received
March 3, 1987
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