The following data is part of a De Novo classification by with the FDA for .

Pre-market Notification Details

DeNovo IDDEN230055
Applicant

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860012858422 DEN230055 000
00860012858415 DEN230055 000
00860012858408 DEN230055 000
00860012858439 DEN230055 000

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.