FDA 510(k)

EXAC TRAC 2.0 (NOVALIS BODY MODULE)

K-Number: K003285 · 2001-07-31

Decision Date2001-07-31

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EXAC TRAC 2.0 (NOVALIS BODY MODULE) is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2001-07-31 under 510(k) number K003285. 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 EXAC TRAC 2.0 (NOVALIS BODY MODULE)?

EXAC TRAC 2.0 (NOVALIS BODY MODULE) is a medical device that received FDA 510(k) clearance on 2001-07-31. The listed applicant is Brainlab AG. The 510(k) number is K003285.

When did EXAC TRAC 2.0 (NOVALIS BODY MODULE) receive FDA 510(k) clearance?

EXAC TRAC 2.0 (NOVALIS BODY MODULE) received FDA 510(k) clearance on 2001-07-31, under 510(k) number K003285.

Who is the listed applicant for EXAC TRAC 2.0 (NOVALIS BODY MODULE)?

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 EXAC TRAC 2.0 (NOVALIS BODY MODULE)?

The FDA product code for EXAC TRAC 2.0 (NOVALIS BODY MODULE) is IYE.

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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.