FDA.reportPublic FDA data

CAPTION HEALTH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30166650373016665037CAPTION HEALTH1N2020-04-252000 Sierra Point Parkway 8th Floor Brisbane CA US 94005

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2391941964706319K173780EchoMD Automated Ejection Fraction SoftwareLLZ2018-06-14
2391941678380003DEN190040Caption GuidanceQJU2020-02-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QJU12020-02-07
LLZ12018-06-14

PMN#