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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 K043238
Device Name COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES
Applicant
Emg Technology Co., Ltd.
914 W. Patapsco Ave.
Baltimore,  MD  21230
Applicant Contact LEONARD FRIER
Correspondent
Emg Technology Co., Ltd.
914 W. Patapsco Ave.
Baltimore,  MD  21230
Correspondent Contact LEONARD FRIER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/22/2004
Decision Date 07/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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