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FDA 510(k)

Grass TWin

K-Number: K173690 · 2018-03-09

Decision Date2018-03-09
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Grass TWin is a medical device manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2018-03-09 under approval number K173690. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Grass TWin?

Grass TWin is a medical device that received FDA 510(k) clearance on 2018-03-09. It is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K173690.

When was Grass TWin approved by the FDA?

Grass TWin received FDA 510(k) clearance on 2018-03-09, under approval number K173690.

What company makes Grass TWin?

Grass TWin is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).

What is the FDA product code for Grass TWin?

The FDA product code for Grass TWin is OLV.

Other Devices by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

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Related Devices (Code: OLV)

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.