510(k) K021490

REEVUE INDIRECT CALORIMETER, MODEL#8100 by Korr Medical Technologies, Inc. — Product Code BZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2003
Date Received
May 9, 2002
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