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FDA 510(k)

Arcus Head Fixation Frame

K-Number: K191701 · 2019-11-15

ApplicantMri Interventions, Inc.
Decision Date2019-11-15
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Arcus Head Fixation Frame is the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K191701. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arcus Head Fixation Frame?

Arcus Head Fixation Frame is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K191701.

When did Arcus Head Fixation Frame receive FDA 510(k) clearance?

Arcus Head Fixation Frame received FDA 510(k) clearance on 2019-11-15, under 510(k) number K191701.

Who is the listed applicant for Arcus Head Fixation Frame?

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

What is the FDA product code for Arcus Head Fixation Frame?

The FDA product code for Arcus Head Fixation Frame is HBL.

Other records listing Mri Interventions, Inc. as applicant

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Related Devices (Code: HBL)

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.

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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.

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