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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 K991685
Device Name HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
Applicant
Medic-Aid , Ltd.
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Applicant Contact PAUL E DRYDEN
Correspondent
Medic-Aid , Ltd.
6329 W.Waterview Ct.
Mccordsville,  IN  46055 -9501
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/17/1999
Decision Date 08/13/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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