FDA 510(k)

WR19 System

K-Number: K172735 · 2018-04-17

Decision Date2018-04-17

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

WR19 System is the device name listed in this FDA 510(k) record. The listed applicant is Zeto, Inc.. It received FDA 510(k) clearance on 2018-04-17 under 510(k) number K172735. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WR19 System?

WR19 System is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Zeto, Inc.. The 510(k) number is K172735.

When did WR19 System receive FDA 510(k) clearance?

WR19 System received FDA 510(k) clearance on 2018-04-17, under 510(k) number K172735.

Who is the listed applicant for WR19 System?

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

What is the FDA product code for WR19 System?

The FDA product code for WR19 System is GWQ.

Other records listing Zeto, Inc. as applicant

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.

K260455New Wave System K233403Flexset System

Related Devices (Code: GWQ)

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity Sas K221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.