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FDA 510(k) Application Details - K223689
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K223689
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
Advance Medical Designs, Inc.
1241 Atlanta Industrial Drive
Marietta, GA 30066 US
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Contact
David Mackie
Other 510(k) Applications for this Contact
Regulation Number
892.1570
More FDA Info for this Regulation Number
Classification Product Code
ITX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/09/2022
Decision Date
08/02/2023
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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