510(k) K912906

MEDGRAPHICS PF/DX by Medical Graphics Corp. — Product Code BZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1992
Date Received
July 2, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Oxygen-Uptake
Device Class
Class II
Regulation Number
868.1730
Review Panel
AN
Submission Type