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FDA 510(k)

Natus Photic Stimulator

K-Number: K173936 · 2018-06-15

Decision Date2018-06-15
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Natus Photic Stimulator is a medical device manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2018-06-15 under approval number K173936. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Natus Photic Stimulator?

Natus Photic Stimulator is a medical device that received FDA 510(k) clearance on 2018-06-15. It is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K173936.

When was Natus Photic Stimulator approved by the FDA?

Natus Photic Stimulator received FDA 510(k) clearance on 2018-06-15, under approval number K173936.

What company makes Natus Photic Stimulator?

Natus Photic Stimulator is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).

What is the FDA product code for Natus Photic Stimulator?

The FDA product code for Natus Photic Stimulator is GWE.

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

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Related Devices (Code: GWE)

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.