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FDA 510(k) Application Details - K051469
Device Classification Name
Ventilator, Emergency, Powered (Resuscitator)
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510(K) Number
K051469
Device Name
Ventilator, Emergency, Powered (Resuscitator)
Applicant
O-TWO MEDICAL TECHNOLOGIES, INC.
7575 KIMBEL ST.
MISSISSAUGA, ONTARIO L5S 1C8 CA
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AMMAR AL-DOJALLY
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Regulation Number
868.5925
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Classification Product Code
BTL
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Date Received
06/03/2005
Decision Date
09/28/2005
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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