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FDA 510(k) Application Details - K123957
Device Classification Name
Ventilator, Emergency, Powered (Resuscitator)
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510(K) Number
K123957
Device Name
Ventilator, Emergency, Powered (Resuscitator)
Applicant
SMITHS MEDICAL INTERNATIONAL LTD.
BRAMINGHAM BUSINESS PARK
ENTERPRISE WAY
LUTON, BEDFORDSHIRE LU3 4BU GB
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LORI BERENDS
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Regulation Number
868.5925
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Classification Product Code
BTL
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Date Received
12/21/2012
Decision Date
09/16/2013
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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