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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 K073242
Device Name PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400
Applicant
Delphi Medical Systems
5725 Delphi Dr.
Troy,  MI  48098
Applicant Contact GILBERT ROQUE
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/19/2007
Decision Date 01/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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