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FDA 510(k)

Natus Quantum

K-Number: K180181 · 2018-02-22

ApplicantNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)
Decision Date2018-02-22
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Natus Quantum is a medical device manufactured by Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2018-02-22 under approval number K180181. 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 Natus Quantum?

Natus Quantum is a medical device that received FDA 510(k) clearance on 2018-02-22. It is manufactured by Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek). The 510(k) number is K180181.

When was Natus Quantum approved by the FDA?

Natus Quantum received FDA 510(k) clearance on 2018-02-22, under approval number K180181.

What company makes Natus Quantum?

Natus Quantum is manufactured by Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek).

What is the FDA product code for Natus Quantum?

The FDA product code for Natus Quantum is GWQ.

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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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