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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name meter, peak flow, spirometry
510(k) Number K982995
Device Name ACCUTRAX, MODEL EPF840
Applicant
KORR MEDICAL TECHNOLOGIES, INC.
3090 EAST 3300 SOUIH #3B
SALT LAKE CITY,  UT  84109 -2106
Applicant Contact SCOTT KOFOED
Correspondent
KORR MEDICAL TECHNOLOGIES, INC.
3090 EAST 3300 SOUIH #3B
SALT LAKE CITY,  UT  84109 -2106
Correspondent Contact SCOTT KOFOED
Regulation Number868.1860
Classification Product Code
BZH  
Date Received08/27/1998
Decision Date 12/04/1998
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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