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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K894441
Device Name DEVILBISS MODEL 6610D
Applicant
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501
Applicant Contact TERRENCE M O'BRIEN
Correspondent
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501
Correspondent Contact TERRENCE M O'BRIEN
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received07/17/1989
Decision Date 10/13/1989
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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