FDA 510(k) Application Details - K233441

Device Classification Name Percussor, Powered-Electric

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510(K) Number K233441
Device Name Percussor, Powered-Electric
Applicant Baxter Healthcare Corportation
One Baxter Parkway
Deerfield, IL 60015 US
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Contact Steven Co
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Regulation Number 868.5665

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Classification Product Code BYI
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Date Received 10/18/2023
Decision Date 03/22/2024
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 K233441


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