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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 K004047
Device Name HOME-AWAY SYSTEM
Applicant
In-X Corp.
6753 E. 47th Ave.
Unit D
Denver,  CO  80216
Applicant Contact CHARLIE HENRY
Correspondent
In-X Corp.
6753 E. 47th Ave.
Unit D
Denver,  CO  80216
Correspondent Contact CHARLIE HENRY
Regulation Number868.5440
Classification Product Code
CAW  
Subsequent Product Code
BYJ  
Date Received12/29/2000
Decision Date 12/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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