FDA 510(k) Application Details - K040574

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K040574
Device Name Ventilator, Continuous, Facility Use
Applicant HAMILTON MEDICAL, INC.
P.O. BOX 30008
RENO, NV 89520 US
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Contact J. DAVID THOMPSON
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 03/04/2004
Decision Date 10/27/2004
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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