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)

NEUROLINK IP MODEL: PK1117

K-Number: K100683 · 2010-04-09

ApplicantNatus Medical Incorporated
Decision Date2010-04-09
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROLINK IP MODEL: PK1117 is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical Incorporated. It received FDA 510(k) clearance on 2010-04-09 under 510(k) number K100683. 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 NEUROLINK IP MODEL: PK1117?

NEUROLINK IP MODEL: PK1117 is a medical device that received FDA 510(k) clearance on 2010-04-09. The listed applicant is Natus Medical Incorporated. The 510(k) number is K100683.

When did NEUROLINK IP MODEL: PK1117 receive FDA 510(k) clearance?

NEUROLINK IP MODEL: PK1117 received FDA 510(k) clearance on 2010-04-09, under 510(k) number K100683.

Who is the listed applicant for NEUROLINK IP MODEL: PK1117?

The FDA 510(k) record lists Natus Medical Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROLINK IP MODEL: PK1117?

The FDA product code for NEUROLINK IP MODEL: PK1117 is GWQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Natus Medical Incorporated 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.

K182178neoBLUE blanket LED Phototherapy SystemK182263RetCam 3 ; RetCam Shuttle ; RetCam PortableK160745neoBLUE compact LED Phototherapy SystemK160305neoBLUE® LED Phototherapy SystemK112247A BAER WITH ABAER I/O FUNCTIONK111618AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION

View all 8 devices →

Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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.

↑