FDA 510(k) Application Details - K041473

Device Classification Name Ventilator, Emergency, Powered (Resuscitator)

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510(K) Number K041473
Device Name Ventilator, Emergency, Powered (Resuscitator)
Applicant VORTRAN MEDICAL TECHNOLOGY 1, INC.
1804 TRIBUTE RD., SUITE F
SACRAMENTO, CA 95815 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 06/02/2004
Decision Date 07/15/2004
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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