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FDA 510(k) Application Details - K210747
Device Classification Name
More FDA Info for this Device
510(K) Number
K210747
Device Name
Caption Interpretation Automated Ejection Fraction Software
Applicant
Caption Health
2000 Sierra Point Pkwy
Brisbane, CA 94005 US
Other 510(k) Applications for this Company
Contact
Sam Surette
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/12/2021
Decision Date
01/19/2022
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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