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FDA 510(k)

HEAD FIXATION ARC AND TABLE BASE

K-Number: K091439 · 2009-08-25

ApplicantSurgivision, Inc.
Decision Date2009-08-25
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HEAD FIXATION ARC AND TABLE BASE is the device name listed in this FDA 510(k) record. The listed applicant is Surgivision, Inc.. It received FDA 510(k) clearance on 2009-08-25 under 510(k) number K091439. 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 HEAD FIXATION ARC AND TABLE BASE?

HEAD FIXATION ARC AND TABLE BASE is a medical device that received FDA 510(k) clearance on 2009-08-25. The listed applicant is Surgivision, Inc.. The 510(k) number is K091439.

When did HEAD FIXATION ARC AND TABLE BASE receive FDA 510(k) clearance?

HEAD FIXATION ARC AND TABLE BASE received FDA 510(k) clearance on 2009-08-25, under 510(k) number K091439.

Who is the listed applicant for HEAD FIXATION ARC AND TABLE BASE?

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

What is the FDA product code for HEAD FIXATION ARC AND TABLE BASE?

The FDA product code for HEAD FIXATION ARC AND TABLE BASE is HBL.

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Other records listing Surgivision, Inc. 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.

K102101SURGIVISION MR COMPATIBLE VENTRICULAR CANNULAK100836CLEARPOINT SYSTEMK091343MRI NEURO DRAPE

Related Devices (Code: HBL)

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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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