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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name computer, oxygen-uptake
510(k) Number K021490
Device Name REEVUE INDIRECT CALORIMETER, MODEL#8100
Applicant
KORR MEDICAL TECHNOLOGIES, INC.
3090 EAST 3300 SOUTH
SUITE 100
SALT LAKE CITY,  UT  84109
Applicant Contact SCOTT A KOFOED
Correspondent
KORR MEDICAL TECHNOLOGIES, INC.
3090 EAST 3300 SOUTH
SUITE 100
SALT LAKE CITY,  UT  84109
Correspondent Contact SCOTT A KOFOED
Regulation Number868.1730
Classification Product Code
BZL  
Date Received05/09/2002
Decision Date 01/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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