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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 K060497
Device Name BABYAIR
Applicant
PROMEDIC, INC.
3460 POINTE CREEK CT.
#102
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
PROMEDIC, INC.
3460 POINTE CREEK CT.
#102
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/24/2006
Decision Date 07/11/2006
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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