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FDA 510(k) Application Details - K200733
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K200733
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
Boston Scientific Corporation
3 Scimed Place
Maple Grove, MN 55311 US
Other 510(k) Applications for this Company
Contact
Jennifer L. Foley
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
03/20/2020
Decision Date
04/17/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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