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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 K013223
Device Name PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
Applicant
Litton Systems, Inc.
2734 Hickory Grove Rd.
Davenport,  IA  52804
Applicant Contact GARY BYRD
Correspondent
Litton Systems, Inc.
2734 Hickory Grove Rd.
Davenport,  IA  52804
Correspondent Contact GARY BYRD
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/27/2001
Decision Date 02/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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