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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 K042546
Device Name FUNHALER, MODEL FH 101
Applicant
Infamed , Ltd.
20310 SW 48th St.
South West Ranches,  FL  33332
Applicant Contact JOHN D GREENBAUM
Correspondent
Infamed , Ltd.
20310 SW 48th St.
South West Ranches,  FL  33332
Correspondent Contact JOHN D GREENBAUM
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/20/2004
Decision Date 01/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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