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FDA 510(k)

TMS-Cobot TS MV

K-Number: K182768 · 2019-02-17

ApplicantAxilum Robotics
Decision Date2019-02-17
Product CodeQFF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TMS-Cobot TS MV is the device name listed in this FDA 510(k) record. The listed applicant is Axilum Robotics. It received FDA 510(k) clearance on 2019-02-17 under 510(k) number K182768. The device is classified under product code QFF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TMS-Cobot TS MV?

TMS-Cobot TS MV is a medical device that received FDA 510(k) clearance on 2019-02-17. The listed applicant is Axilum Robotics. The 510(k) number is K182768.

When did TMS-Cobot TS MV receive FDA 510(k) clearance?

TMS-Cobot TS MV received FDA 510(k) clearance on 2019-02-17, under 510(k) number K182768.

Who is the listed applicant for TMS-Cobot TS MV?

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

What is the FDA product code for TMS-Cobot TS MV?

The FDA product code for TMS-Cobot TS MV is QFF.

Related Devices (Code: QFF)

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.

K261471Zeta TMS Navigation SystemZeta Surgical, Inc.

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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