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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescent Immunoassay Gentamicin
510(k) Number K801867
Device Name DISPOSABLE MEDICATION NEBULIZER
Applicant
HOSPITAX
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HOSPITAX
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.3450
Classification Product Code
LCQ  
Date Received08/05/1980
Decision Date 08/20/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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