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FDA 510(k)

L100 Go System

K-Number: K200262 · 2020-03-04

ApplicantBioness, Inc.
Decision Date2020-03-04
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

L100 Go System is the device name listed in this FDA 510(k) record. The listed applicant is Bioness, Inc.. It received FDA 510(k) clearance on 2020-03-04 under 510(k) number K200262. 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 L100 Go System?

L100 Go System is a medical device that received FDA 510(k) clearance on 2020-03-04. The listed applicant is Bioness, Inc.. The 510(k) number is K200262.

When did L100 Go System receive FDA 510(k) clearance?

L100 Go System received FDA 510(k) clearance on 2020-03-04, under 510(k) number K200262.

Who is the listed applicant for L100 Go System?

The FDA 510(k) record lists Bioness, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for L100 Go System?

The FDA product code for L100 Go System is GZI.

Other records listing Bioness, Inc. as applicant

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Related Devices (Code: GZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242704Synchrony (20-3000)Synapse Biomedical, Inc.K243828CIONIC NEURAL SLEEVE (NS-200)Cionic, Inc.K240632Neuvotion NeuStim NN-01Neuvotion, Inc.K233006MyndMove, MyndMove 2.0Myndtec, Inc.K230997EvoWalk 1.0 SystemEvolution Devices, Inc.K221823Cionic Neural Sleeve NS-100Cionic

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.

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