FDA 510(k)

EXACTRAC 4.0 AND EXACTRAC X-RAY 6D

K-Number: K040585 · 2004-05-11

Decision Date2004-05-11

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EXACTRAC 4.0 AND EXACTRAC X-RAY 6D is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2004-05-11 under 510(k) number K040585. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTRAC 4.0 AND EXACTRAC X-RAY 6D?

EXACTRAC 4.0 AND EXACTRAC X-RAY 6D is a medical device that received FDA 510(k) clearance on 2004-05-11. The listed applicant is Brainlab AG. The 510(k) number is K040585.

When did EXACTRAC 4.0 AND EXACTRAC X-RAY 6D receive FDA 510(k) clearance?

EXACTRAC 4.0 AND EXACTRAC X-RAY 6D received FDA 510(k) clearance on 2004-05-11, under 510(k) number K040585.

Who is the listed applicant for EXACTRAC 4.0 AND EXACTRAC X-RAY 6D?

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

What is the FDA product code for EXACTRAC 4.0 AND EXACTRAC X-RAY 6D?

The FDA product code for EXACTRAC 4.0 AND EXACTRAC X-RAY 6D is IYE.

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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.