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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 K051887
Device Name PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)
Applicant
CARLETON LIFE SUPPORT SYSTEMS INC.
2734 HICKORY GROVE RD.
DAVENPORT,  IA  52804 -1203
Applicant Contact GARY BYRD
Correspondent
CARLETON LIFE SUPPORT SYSTEMS INC.
2734 HICKORY GROVE RD.
DAVENPORT,  IA  52804 -1203
Correspondent Contact GARY BYRD
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/12/2005
Decision Date 09/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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