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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 K052438
Device Name EMG HANDLE NEBULIZER NB02 SERIES
Applicant
Emg Technology Co., Ltd.
98 Stanton St.
Wilkes Barre,  PA  18702
Applicant Contact GENE R KULON
Correspondent
Emg Technology Co., Ltd.
98 Stanton St.
Wilkes Barre,  PA  18702
Correspondent Contact GENE R KULON
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/06/2005
Decision Date 01/31/2006
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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