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FDA 510(k)

Encore Neutral

K-Number: K162826 · 2017-06-15

ApplicantRymed Technologies, LLC
Decision Date2017-06-15
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Encore Neutral is a medical device manufactured by Rymed Technologies, LLC. It received FDA 510(k) clearance on 2017-06-15 under approval number K162826. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Encore Neutral?

Encore Neutral is a medical device that received FDA 510(k) clearance on 2017-06-15. It is manufactured by Rymed Technologies, LLC. The 510(k) number is K162826.

When was Encore Neutral approved by the FDA?

Encore Neutral received FDA 510(k) clearance on 2017-06-15, under approval number K162826.

What company makes Encore Neutral?

Encore Neutral is manufactured by Rymed Technologies, LLC.

What is the FDA product code for Encore Neutral?

The FDA product code for Encore Neutral is FPA.

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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.

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