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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 K100121
Device Name MODEL 300157 CPAP SYSTEM
Applicant
AEIOMED, INC.
1313 5th street se, ste 205
minneapolis,  MN  55414
Applicant Contact darin busch
Correspondent
AEIOMED, INC.
1313 5th street se, ste 205
minneapolis,  MN  55414
Correspodent Contact darin busch
Regulation Number868.5905
Classification Product Code
BZD  
Date Received01/15/2010
Decision Date 07/13/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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