510(k) K840439

RECOMED CARDIAC OUTPUT METER 236067- by Litton Medical Electronics — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1984
Date Received
February 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type