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FDA 510(k)

Neurosoft TMS

K-Number: K160309 · 2016-12-22

ApplicantTeleemg, LLC
Decision Date2016-12-22
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Neurosoft TMS is the device name listed in this FDA 510(k) record. The listed applicant is Teleemg, LLC. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K160309. 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 Neurosoft TMS?

Neurosoft TMS is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Teleemg, LLC. The 510(k) number is K160309.

When did Neurosoft TMS receive FDA 510(k) clearance?

Neurosoft TMS received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160309.

Who is the listed applicant for Neurosoft TMS?

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

What is the FDA product code for Neurosoft TMS?

The FDA product code for Neurosoft TMS is OBP.

Other records listing Teleemg, LLC 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.

K250689CloudTMS EdgeK233742CloudTMS Edge for OCDK221129CloudTMS for OCDK173441Neurosoft TMS (also CloudTMS)

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.

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.K251391BrainsWay Deep TMS SystemBrainsway , Ltd.

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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