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)

Nexstim Navigated Brain Therapy (NBT) System 2

K-Number: K182700 · 2019-03-22

ApplicantNexstim Plc
Decision Date2019-03-22
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Nexstim Navigated Brain Therapy (NBT) System 2 is the device name listed in this FDA 510(k) record. The listed applicant is Nexstim Plc. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K182700. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nexstim Navigated Brain Therapy (NBT) System 2?

Nexstim Navigated Brain Therapy (NBT) System 2 is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Nexstim Plc. The 510(k) number is K182700.

When did Nexstim Navigated Brain Therapy (NBT) System 2 receive FDA 510(k) clearance?

Nexstim Navigated Brain Therapy (NBT) System 2 received FDA 510(k) clearance on 2019-03-22, under 510(k) number K182700.

Who is the listed applicant for Nexstim Navigated Brain Therapy (NBT) System 2?

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

What is the FDA product code for Nexstim Navigated Brain Therapy (NBT) System 2?

The FDA product code for Nexstim Navigated Brain Therapy (NBT) System 2 is OBP.

Other records listing Nexstim Plc 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.

K171902Nexstim Navigated Brain Therapy (NBT) System 2

Related Devices (Code: OBP)

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.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix Medical, 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.

↑