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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 K992917
Device Name AEROCHAMBER PLUS VALVED HOLDING CHAMBER
Applicant
TRUDELL MEDICAL INT'L
725 THIRD ST.
LONDON, ONTARIO,  CA N5V 5G4
Applicant Contact DARRYL FISCHER
Correspondent
TRUDELL MEDICAL INT'L
725 THIRD ST.
LONDON, ONTARIO,  CA N5V 5G4
Correspondent Contact DARRYL FISCHER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/30/1999
Decision Date 09/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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