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510(k) K860951

KONTRON CUTANEOUS PO2 MONITOR 820 by Kontron Instruments, Inc. — Product Code KLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1986
Date Received
March 12, 1986
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

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