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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 E. 3300 Souih #3b
Salt Lake City,  UT  84109
Applicant Contact SCOTT KOFOED
Correspondent
Korr Medical Technologies, Inc.
3090 E. 3300 Souih #3b
Salt Lake City,  UT  84109
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
Predetermined Change
Control Plan Authorized		 No
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