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

Pre-market Notification Details

DeNovo IDDEN190055
Applicant

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850002960068 DEN190055 000
00850002960051 DEN190055 000
00850002960044 DEN190055 000
00850002960037 DEN190055 000
00850002960020 DEN190055 000
00850002960006 DEN190055 000

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