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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
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