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FDA 510(k) Application Details - K241465
Device Classification Name
Mixer, Breathing Gases, Anesthesia Inhalation
More FDA Info for this Device
510(K) Number
K241465
Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Applicant
Parker Hannifin Corporation
245 Township Line Road
Hatfield, PA 19440 US
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Contact
Deanna Perry
Other 510(k) Applications for this Contact
Regulation Number
868.5330
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Classification Product Code
BZR
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More FDA Info for this Product Code
Date Received
05/23/2024
Decision Date
09/19/2024
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
FDA Source Information for K241465
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