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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 K091272
Device Name BESMED JET NEBULIZER BOTTLE SET
Applicant
BESMED HEALTH BUSINESS CORP.
58 FU-CHIUN ST.
HSIN CHU CITY,  TW 300
Applicant Contact Ke-Min Jen
Correspondent
BESMED HEALTH BUSINESS CORP.
58 FU-CHIUN ST.
HSIN CHU CITY,  TW 300
Correspondent Contact Ke-Min Jen
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/30/2009
Decision Date 11/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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