FDA 510(k)

M3 (MICRO-MULTILEAF COLLIMATOR)

K-Number: K020860 · 2002-06-06

Decision Date2002-06-06

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

M3 (MICRO-MULTILEAF COLLIMATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2002-06-06 under 510(k) number K020860. 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 M3 (MICRO-MULTILEAF COLLIMATOR)?

M3 (MICRO-MULTILEAF COLLIMATOR) is a medical device that received FDA 510(k) clearance on 2002-06-06. The listed applicant is Brainlab AG. The 510(k) number is K020860.

When did M3 (MICRO-MULTILEAF COLLIMATOR) receive FDA 510(k) clearance?

M3 (MICRO-MULTILEAF COLLIMATOR) received FDA 510(k) clearance on 2002-06-06, under 510(k) number K020860.

Who is the listed applicant for M3 (MICRO-MULTILEAF COLLIMATOR)?

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 M3 (MICRO-MULTILEAF COLLIMATOR)?

The FDA product code for M3 (MICRO-MULTILEAF COLLIMATOR) 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.