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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 K981047
Device Name FRESH AIR
Applicant
Colorado Medtech, Inc.
6175 Longbow Dr.
Boulder,  CO  80301
Applicant Contact LOCKETT E WOOD
Correspondent
Colorado Medtech, Inc.
6175 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact LOCKETT E WOOD
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/20/1998
Decision Date 09/16/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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