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FDA 510(k)

Background Pattern Classification [BPc(TM)]

K-Number: K152301 · 2016-06-03

ApplicantNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Decision Date2016-06-03
Product CodeOMA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Background Pattern Classification [BPc(TM)] 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 2016-06-03 under 510(k) number K152301. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Background Pattern Classification [BPc(TM)]?

Background Pattern Classification [BPc(TM)] is a medical device that received FDA 510(k) clearance on 2016-06-03. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K152301.

When did Background Pattern Classification [BPc(TM)] receive FDA 510(k) clearance?

Background Pattern Classification [BPc(TM)] received FDA 510(k) clearance on 2016-06-03, under 510(k) number K152301.

Who is the listed applicant for Background Pattern Classification [BPc(TM)]?

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 Background Pattern Classification [BPc(TM)]?

The FDA product code for Background Pattern Classification [BPc(TM)] is OMA.

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

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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.

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