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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 K042944
Device Name HOME-AWAY SYSTEM, MODEL 1041
Applicant
In-X Corporation
6753 E. 47th Ave.
Unit D
Denver,  CO  80216
Applicant Contact DOUGLAS POWELL
Correspondent
In-X Corporation
6753 E. 47th Ave.
Unit D
Denver,  CO  80216
Correspondent Contact DOUGLAS POWELL
Regulation Number868.5440
Classification Product Code
CAW  
Subsequent Product Code
BYJ  
Date Received10/25/2004
Decision Date 04/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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