FDA 510(k) Application Details - K073261

Device Classification Name Ventilator, Emergency, Powered (Resuscitator)

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510(K) Number K073261
Device Name Ventilator, Emergency, Powered (Resuscitator)
Applicant VORTRAN MEDICAL TECHNOLOGY 1, INC.
21 GOLDEN LAND COURT
SACRAMENTO, CA 95834 US
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Contact JAMES LEE
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Regulation Number 868.5925

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Classification Product Code BTL
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Date Received 11/20/2007
Decision Date 05/23/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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