510(k) K922660

PHYSIO-DYNE EASI - LAB by Physio-Dyne — Product Code BZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1993
Date Received
June 3, 1992
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