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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Intermittent Mandatory Ventilation (Imv)
510(k) Number K811908
Device Name IMV MANIFOLDS
Applicant
Airlife, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Airlife, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent Contact - -
Regulation Number868.5955
Classification Product Code
CBO  
Date Received07/01/1981
Decision Date 07/16/1981
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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