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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K861104
Device Name VARIABLE HIGH FLOW DOWNS CPAP GENERATOR
Applicant
Med Air Technology, Inc.
2519 E. Kearney
Springfield,  MO  65803
Applicant Contact LOIS A HANSEN
Correspondent
Med Air Technology, Inc.
2519 E. Kearney
Springfield,  MO  65803
Correspondent Contact LOIS A HANSEN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received03/24/1986
Decision Date 04/28/1986
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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