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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Tracheal Tube
510(k) Number K810737
Device Name ENDOTRACHEAL TUBE HOLDER
Applicant
Aircare Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Aircare Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5770
Classification Product Code
CBH  
Date Received03/18/1981
Decision Date 04/17/1981
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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