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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 K072688
Device Name LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000
Applicant
INTERNATIONAL BIOPHYSICS CORP.
2101-2 E. ST. ELMO
SUITE 275
AUSTIN,  TX  78744
Applicant Contact DAVID SHOCKLEY
Correspondent
INTERNATIONAL BIOPHYSICS CORP.
2101-2 E. ST. ELMO
SUITE 275
AUSTIN,  TX  78744
Correspondent Contact DAVID SHOCKLEY
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/24/2007
Decision Date 01/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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