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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Hematocrit Measuring
510(k) Number K924167
Device Name CRIT-LINE
Applicant
Noninvasive Medical Technology Corp.
333 Second St., Suite 8
Ogden,  UT  84404
Applicant Contact JAMES M COINIS
Correspondent
Noninvasive Medical Technology Corp.
333 Second St., Suite 8
Ogden,  UT  84404
Correspondent Contact JAMES M COINIS
Regulation Number864.6400
Classification Product Code
JPI  
Date Received08/19/1992
Decision Date 05/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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