L300 Go System

Stimulator, Neuromuscular, External Functional

Bioness, Inc.

The following data is part of a premarket notification filed by Bioness, Inc. with the FDA for L300 Go System.

Pre-market Notification Details

Device IDK173682
510k NumberK173682
Device Name:L300 Go System
ClassificationStimulator, Neuromuscular, External Functional
Applicant Bioness, Inc. 25103 Rye Canyon Loop Valencia,  CA  91355
ContactMercedes Bayani
CorrespondentMary Dadone
Bioness, Inc. 25103 Rye Canyon Loop Valencia,  CA  91355
Product CodeGZI  
CFR Regulation Number882.5810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-01
Decision Date2018-03-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815962020078 K173682 000

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