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FDA 510(k)

EXACTRAC GATING

K-Number: K033287 · 2003-12-19

ApplicantBrainlab AG
Decision Date2003-12-19
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXACTRAC GATING is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K033287. 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 GATING?

EXACTRAC GATING is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Brainlab AG. The 510(k) number is K033287.

When did EXACTRAC GATING receive FDA 510(k) clearance?

EXACTRAC GATING received FDA 510(k) clearance on 2003-12-19, under 510(k) number K033287.

Who is the listed applicant for EXACTRAC GATING?

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 GATING?

The FDA product code for EXACTRAC GATING 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.

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