Bioflux Software II

Recorder, Magnetic Tape, Medical

Biotricity

The following data is part of a premarket notification filed by Biotricity with the FDA for Bioflux Software Ii.

Pre-market Notification Details

Device IDK201040
510k NumberK201040
Device Name:Bioflux Software II
ClassificationRecorder, Magnetic Tape, Medical
Applicant Biotricity 275 Shoreline Drive, Suite 150 Redwood City,  CA  94065
ContactSpencer Ladow
CorrespondentSpencer Ladow
Biotricity 275 Shoreline Drive, Suite 150 Redwood City,  CA  94065
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-01
Decision Date2020-07-29

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