FDA 510(k)

NOVALIS (SHAPED BEAM SURGERY SYSTEM)

K-Number: K002509 · 2000-11-03

Decision Date2000-11-03

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

NOVALIS (SHAPED BEAM SURGERY SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2000-11-03 under 510(k) number K002509. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVALIS (SHAPED BEAM SURGERY SYSTEM)?

NOVALIS (SHAPED BEAM SURGERY SYSTEM) is a medical device that received FDA 510(k) clearance on 2000-11-03. The listed applicant is Brainlab AG. The 510(k) number is K002509.

When did NOVALIS (SHAPED BEAM SURGERY SYSTEM) receive FDA 510(k) clearance?

NOVALIS (SHAPED BEAM SURGERY SYSTEM) received FDA 510(k) clearance on 2000-11-03, under 510(k) number K002509.

Who is the listed applicant for NOVALIS (SHAPED BEAM SURGERY SYSTEM)?

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 NOVALIS (SHAPED BEAM SURGERY SYSTEM)?

The FDA product code for NOVALIS (SHAPED BEAM SURGERY SYSTEM) is MUJ.

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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.