FDA 510(k)

MLCI2

K-Number: K082122 · 2008-08-29

Decision Date2008-08-29

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MLCI2 is the device name listed in this FDA 510(k) record. The listed applicant is Elekta , Ltd.. It received FDA 510(k) clearance on 2008-08-29 under 510(k) number K082122. 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 MLCI2?

MLCI2 is a medical device that received FDA 510(k) clearance on 2008-08-29. The listed applicant is Elekta , Ltd.. The 510(k) number is K082122.

When did MLCI2 receive FDA 510(k) clearance?

MLCI2 received FDA 510(k) clearance on 2008-08-29, under 510(k) number K082122.

Who is the listed applicant for MLCI2?

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

What is the FDA product code for MLCI2?

The FDA product code for MLCI2 is IYE.

Other records listing Elekta , Ltd. as applicant

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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.