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FDA 510(k)

Natus Photic Stimulator

K-Number: K173936 · 2018-06-15

ApplicantNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Decision Date2018-06-15
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Natus Photic Stimulator is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2018-06-15 under 510(k) 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. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K173936.

When did Natus Photic Stimulator receive FDA 510(k) clearance?

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

Who is the listed applicant for Natus Photic Stimulator?

The FDA 510(k) record lists Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Natus Photic Stimulator?

The FDA product code for Natus Photic Stimulator is GWE.

Other records listing Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) as applicant

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Related Devices (Code: GWE)

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.

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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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