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FDA 510(k) Application Details - K230931
Device Classification Name
Gas-Machine, Anesthesia
More FDA Info for this Device
510(K) Number
K230931
Device Name
Gas-Machine, Anesthesia
Applicant
DrΣgerwerk AG Co. KGaA
Moislinger Allee 53-55
Lⁿbeck 23542 DE
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Contact
Marianne Selent
Other 510(k) Applications for this Contact
Regulation Number
868.5160
More FDA Info for this Regulation Number
Classification Product Code
BSZ
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More FDA Info for this Product Code
Date Received
04/03/2023
Decision Date
07/23/2023
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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