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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K062811
Device Name DPILOG, MODEL DPC-512
Applicant
LIFE OUTCOMES, INC.
3957 BLUE PINE CIRCLE
HIGHLANDS RANCH,  CO  80126 -8077
Applicant Contact CHARLES M HART
Correspondent
LIFE OUTCOMES, INC.
3957 BLUE PINE CIRCLE
HIGHLANDS RANCH,  CO  80126 -8077
Correspondent Contact CHARLES M HART
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/19/2006
Decision Date 12/20/2006
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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