FDA 510(k) Application Details - K241465

Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation

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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
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Regulation Number 868.5330

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Classification Product Code BZR
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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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