L300 Go System
K-Number: K190285 · 2019-03-14
ApplicantBioness, Inc.
Decision Date2019-03-14
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
L300 Go System is a medical device manufactured by Bioness, Inc.. It received FDA 510(k) clearance on 2019-03-14 under approval number K190285. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the L300 Go System?
L300 Go System is a medical device that received FDA 510(k) clearance on 2019-03-14. It is manufactured by Bioness, Inc.. The 510(k) number is K190285.
When was L300 Go System approved by the FDA?
L300 Go System received FDA 510(k) clearance on 2019-03-14, under approval number K190285.
What company makes L300 Go System?
L300 Go System is manufactured by Bioness, Inc..
What is the FDA product code for L300 Go System?
The FDA product code for L300 Go System is GZI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.