FDA 510(k) Application Details - K072926

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K072926
Device Name Ventilator, Continuous, Facility Use
Applicant LINDE GAS THERAPEUTICS
AGA AB
SE-181 81LIDINGO SE
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Contact ANN-CATHRIN JAREMAN
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 10/15/2007
Decision Date 10/15/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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