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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name humidifier, non-direct patient interface (home-use)
510(k) Number K781591
Device Name NEBULIZER/HUMIDIFIER MODEL EH 147B
Applicant
MISTOGEN EQUIPMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MISTOGEN EQUIPMENT CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received09/18/1978
Decision Date 10/16/1978
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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