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FDA 510(k)

MYTIS ARROW XXXX

K-Number: K052254 · 2006-06-01

ApplicantBrainbase Corporation
Decision Date2006-06-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MYTIS ARROW XXXX is the device name listed in this FDA 510(k) record. The listed applicant is Brainbase Corporation. It received FDA 510(k) clearance on 2006-06-01 under 510(k) number K052254. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYTIS ARROW XXXX?

MYTIS ARROW XXXX is a medical device that received FDA 510(k) clearance on 2006-06-01. The listed applicant is Brainbase Corporation. The 510(k) number is K052254.

When did MYTIS ARROW XXXX receive FDA 510(k) clearance?

MYTIS ARROW XXXX received FDA 510(k) clearance on 2006-06-01, under 510(k) number K052254.

Who is the listed applicant for MYTIS ARROW XXXX?

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

What is the FDA product code for MYTIS ARROW XXXX?

The FDA product code for MYTIS ARROW XXXX is DZE.

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Other records listing Brainbase Corporation 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.

K083372ARROWBONE-A, ARROWBONE-BK063236BETA-POWDER

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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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