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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 K063449
Device Name DELUXE NEBULIZER
Applicant
ACCESS POINT MEDICAL, L.L.C.
835 NW PEBBLE BEACH WAY
BEAVERTON,  OR  97006
Applicant Contact JAMES W SANDBERG
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONROY
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/15/2006
Decision Date 03/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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