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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 K963042
Device Name INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853
Applicant
Sim Italia S.R.L.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent
Sim Italia S.R.L.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/05/1996
Decision Date 11/01/1996
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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