510(k) K840102

ARTERIAL BLOOD GAS INTERPRETATION PROG by M. D. Software, Inc. — Product Code CCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
January 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
Device Class
Class II
Regulation Number
868.1200
Review Panel
AN
Submission Type