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FDA 510(k)

WR19 System

K-Number: K172735 · 2018-04-17

ApplicantZeto, Inc.
Decision Date2018-04-17
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WR19 System is a medical device manufactured by Zeto, Inc.. It received FDA 510(k) clearance on 2018-04-17 under approval 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. It is manufactured by Zeto, Inc.. The 510(k) number is K172735.

When was WR19 System approved by the FDA?

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

What company makes WR19 System?

WR19 System is manufactured by Zeto, Inc..

What is the FDA product code for WR19 System?

The FDA product code for WR19 System is GWQ.

Other Devices by Zeto, Inc.

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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.

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