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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K052563
Device Name INOGEN SATELLITE CONSERVER, MODEL SC-100
Applicant
MEDICAL ELECTRONIC DEVICES, INC.
2807 OREGON CT. #D6
TORRANCE,  CA  90503
Applicant Contact THOMAS WENZEL
Correspondent
MEDICAL ELECTRONIC DEVICES, INC.
2807 OREGON CT. #D6
TORRANCE,  CA  90503
Correspondent Contact THOMAS WENZEL
Regulation Number868.5905
Classification Product Code
NFB  
Date Received09/19/2005
Decision Date 10/24/2005
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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