Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1604524823
Device Listing 1604524823
Listing Summary
#
Listing key
1604524823
Premarket submission
K233409
Device
Eko Low Ejection Fraction Tool (ELEFT)
Applicant
Eko Health, Inc.
Product code
QYE
Decision date
2024-03-28
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
182950
3011651230
3011651230
Eko Health, Inc.
1
N
2026-01-01
2100 Powell St, Suite 300 Emeryville CA US 94608