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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 a medical device manufactured by Mri Interventions, Inc.. It received FDA 510(k) clearance on 2019-11-15 under approval 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. It is manufactured by Mri Interventions, Inc.. The 510(k) number is K191701.

When was Arcus Head Fixation Frame approved by the FDA?

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

What company makes Arcus Head Fixation Frame?

Arcus Head Fixation Frame is manufactured by Mri Interventions, Inc..

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

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

Other Devices by Mri Interventions, Inc.

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Related Devices (Code: HBL)

K163322TZ SKULL PIN AdultTz Medical, Inc. K191979DORO QR3 XTom Headholder SystemPro Med Instruments GmbH K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)Pro Med Instruments GmbH K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH K203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)Pro Med Instruments GmbH

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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