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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name heater, breathing system w/wo controller (not humidifier or nebulizer
510(k) Number K170378
Device Name AirLife Adult Heated Wire BiPAP/NIV Circuit
Applicant
Vyaire Medical
75 North Fairway Drive
Vernon Hills,  IL  60061
Applicant Contact Sharon Nichols
Correspondent
Vyaire Medical
75 North Fairway Drive
Vernon Hills,  IL  60061
Correspondent Contact Colleen Watson (O'Keeffe)
Regulation Number868.5270
Classification Product Code
BZE  
Date Received02/07/2017
Decision Date 09/14/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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