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FDA 510(k)

ABARIS

K-Number: K053610 · 2006-04-19

ApplicantTraxtal Technologies, Inc.
Decision Date2006-04-19
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ABARIS is the device name listed in this FDA 510(k) record. The listed applicant is Traxtal Technologies, Inc.. It received FDA 510(k) clearance on 2006-04-19 under 510(k) number K053610. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABARIS?

ABARIS is a medical device that received FDA 510(k) clearance on 2006-04-19. The listed applicant is Traxtal Technologies, Inc.. The 510(k) number is K053610.

When did ABARIS receive FDA 510(k) clearance?

ABARIS received FDA 510(k) clearance on 2006-04-19, under 510(k) number K053610.

Who is the listed applicant for ABARIS?

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

What is the FDA product code for ABARIS?

The FDA product code for ABARIS is JAK.

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Related Devices (Code: JAK)

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

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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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