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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Tube, Thorpe, Back-Pressure Compensated
510(k) Number K851288
Device Name OXYGEN DELIVERY MEASURING DEVICE
Applicant
Bar-Dix, Inc.
Rural Route Box 65
Frazee,  MN  56544
Applicant Contact ROBERT J HERDZINA
Correspondent
Bar-Dix, Inc.
Rural Route Box 65
Frazee,  MN  56544
Correspondent Contact ROBERT J HERDZINA
Regulation Number868.2340
Classification Product Code
CAX  
Date Received04/01/1985
Decision Date 09/03/1985
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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