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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K953815
Device Name 5 LPM OXYGEN CONCENTRATOR
Applicant
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501
Applicant Contact GREG CLITES
Correspondent
Devilbiss Health Care, Inc.
1200 E. Main St.
P.O.Box 635
Somerset,  PA  15501
Correspondent Contact GREG CLITES
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/14/1995
Decision Date 11/09/1995
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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