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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K072926
Device Name HELONTIX VENT
Applicant
LINDE GAS THERAPEUTICS
AGA AB
SE-181 81LIDINGO,  SE
Applicant Contact ANN-CATHRIN JAREMAN
Correspondent
LINDE GAS THERAPEUTICS
AGA AB
SE-181 81LIDINGO,  SE
Correspondent Contact ANN-CATHRIN JAREMAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/15/2007
Decision Date 10/15/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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