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FDA 510(k) Application Details - K001686
Device Classification Name
Ventilator, Continuous, Facility Use
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
J. DAVID THOMPSON
Other 510(k) Applications for this Contact
Regulation Number
868.5895
More FDA Info for this Regulation Number
Classification Product Code
CBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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