FDA 510(k) Application Details - K233096

Device Classification Name

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510(K) Number K233096
Device Name PRESSUREALERT« Pressure Monitoring System
Applicant Walgreen Health Solutions, LLC
1316 Sherman Avenue
Evanston, IL 60201 US
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Contact Dawn Bolles
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Regulation Number

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Classification Product Code SBO
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Date Received 09/26/2023
Decision Date 06/21/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233096


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