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FDA 510(k)

ers2 - ergoline Rehabilitation System

K-Number: K212883 · 2022-07-15

ApplicantErgoline GmbH
Decision Date2022-07-15
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ers2 - ergoline Rehabilitation System is a medical device manufactured by Ergoline GmbH. It received FDA 510(k) clearance on 2022-07-15 under approval number K212883. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ers2 - ergoline Rehabilitation System?

ers2 - ergoline Rehabilitation System is a medical device that received FDA 510(k) clearance on 2022-07-15. It is manufactured by Ergoline GmbH. The 510(k) number is K212883.

When was ers2 - ergoline Rehabilitation System approved by the FDA?

ers2 - ergoline Rehabilitation System received FDA 510(k) clearance on 2022-07-15, under approval number K212883.

What company makes ers2 - ergoline Rehabilitation System?

ers2 - ergoline Rehabilitation System is manufactured by Ergoline GmbH.

What is the FDA product code for ers2 - ergoline Rehabilitation System?

The FDA product code for ers2 - ergoline Rehabilitation System is DRG.

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Official Source

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