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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 K921273
Device Name EASIMIST ULTRASONIC NEBULIZER
Applicant
MEDIX CORP.
MEDIX HOUSE, CATHORPE
LUTTERWORTH, LEICS
LE17 6DB, ENGLAND,  GB
Applicant Contact BRIAN JONES
Correspondent
MEDIX CORP.
MEDIX HOUSE, CATHORPE
LUTTERWORTH, LEICS
LE17 6DB, ENGLAND,  GB
Correspondent Contact BRIAN JONES
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/17/1992
Decision Date 04/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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