Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Natus NeuroWorks

K-Number: K200878 · 2020-05-18

ApplicantNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Decision Date2020-05-18
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Natus NeuroWorks 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 2020-05-18 under 510(k) number K200878. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Natus NeuroWorks?

Natus NeuroWorks is a medical device that received FDA 510(k) clearance on 2020-05-18. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K200878.

When did Natus NeuroWorks receive FDA 510(k) clearance?

Natus NeuroWorks received FDA 510(k) clearance on 2020-05-18, under 510(k) number K200878.

Who is the listed applicant for Natus NeuroWorks?

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 NeuroWorks?

The FDA product code for Natus NeuroWorks is OMB.

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

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.

K242930Natus BrainWatch SystemK233649ALGO Pro Newborn Hearing Screener (ALGO Pro)K203500RetCam EnvisionK173936Natus Photic StimulatorK180290Natus Brain Monitor AmplifierK180421Natus NeuroWorks

View all 13 devices →

Related Devices (Code: OMB)

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.

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLCK243743autoSCORE (V 2.0.0)Holberg Eeg ASK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

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.

↑