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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K042945
Device Name AURA CPAP SYSTEM
Applicant
Aeiomed, Inc.
800 Levanger Lane
Stoughton,  WI  53589
Applicant Contact Gary Syring
Correspondent
Aeiomed, Inc.
800 Levanger Lane
Stoughton,  WI  53589
Correspondent Contact Gary Syring
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/25/2004
Decision Date 03/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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