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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 E. 3300 S.
Suite 100
Salt Lake City,  UT  84109
Applicant Contact SCOTT A KOFOED
Correspondent
Korr Medical Technologies, Inc.
3090 E. 3300 S.
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
Predetermined Change
Control Plan Authorized		 No
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