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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 K924322
Device Name FLOW=MED
Applicant
International Electronic Technology Corp.
9025 Rast Kenyon
Denver,  CO  80237
Applicant Contact ROBERT RICHARDS
Correspondent
International Electronic Technology Corp.
9025 Rast Kenyon
Denver,  CO  80237
Correspondent Contact ROBERT RICHARDS
Regulation Number868.1860
Classification Product Code
BZH  
Date Received08/27/1992
Decision Date 04/26/1994
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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