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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 K850711
Device Name INHALATION THERAPY NEBULIZER DEVICE
Applicant
Med USA
319 Waverley Oaks Rd.
Waltham,  MA  02154
Applicant Contact JAMES R RUNDELL
Correspondent
Med USA
319 Waverley Oaks Rd.
Waltham,  MA  02154
Correspondent Contact JAMES R RUNDELL
Regulation Number868.5460
Classification Product Code
KFZ  
Date Received02/22/1985
Decision Date 06/05/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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