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FDA 510(k) Application Details - K230497
Device Classification Name
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510(K) Number
K230497
Device Name
Bladder AI (AIBV01)
Applicant
Exo Inc
4201 Burton Drive
Santa Clara, CA 95054 US
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Contact
Jacqueline Murray
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Regulation Number
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Classification Product Code
QIH
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More FDA Info for this Product Code
Date Received
02/24/2023
Decision Date
06/22/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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