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FDA 510(k) Application Details - K230381
Device Classification Name
More FDA Info for this Device
510(K) Number
K230381
Device Name
Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator
Applicant
CS Medical LLC
2179 East Lyon Station Rd
Creedmoor, NC 27522 US
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Contact
Kendall Ashe
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Regulation Number
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Classification Product Code
PSW
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Date Received
02/13/2023
Decision Date
06/07/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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