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FDA 510(k)

LINACwatch, LinacView

K-Number: K172534 · 2017-10-27

ApplicantQualiformed Sarl
Decision Date2017-10-27
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LINACwatch, LinacView is a medical device manufactured by Qualiformed Sarl. It received FDA 510(k) clearance on 2017-10-27 under approval number K172534. 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 LINACwatch, LinacView?

LINACwatch, LinacView is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Qualiformed Sarl. The 510(k) number is K172534.

When was LINACwatch, LinacView approved by the FDA?

LINACwatch, LinacView received FDA 510(k) clearance on 2017-10-27, under approval number K172534.

What company makes LINACwatch, LinacView?

LINACwatch, LinacView is manufactured by Qualiformed Sarl.

What is the FDA product code for LINACwatch, LinacView?

The FDA product code for LINACwatch, LinacView is IYE.

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Official Source

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