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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 K940835
Device Name PEAKLOG AND DISPLAY SOFTWARE
Applicant
MEDTRAC TECHNOLOGIES CORP.
12364 ALAMEDA PKWY.
SUITE 115
LAKEWOOD,  CO  80228
Applicant Contact LINDA L NELSON
Correspondent
MEDTRAC TECHNOLOGIES CORP.
12364 ALAMEDA PKWY.
SUITE 115
LAKEWOOD,  CO  80228
Correspondent Contact LINDA L NELSON
Regulation Number868.1860
Classification Product Code
BZH  
Date Received02/23/1994
Decision Date 11/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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