FDA 510(k) Application Details - K001686

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K001686
Device Name Ventilator, Continuous, Facility Use
Applicant HAMILTON MEDICAL, INC.
505 EDISON WAY
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 05/18/2000
Decision Date 06/23/2000
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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