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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 the device name listed in this FDA 510(k) record. The listed applicant is Ergoline GmbH. It received FDA 510(k) clearance on 2022-07-15 under 510(k) 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. The listed applicant is Ergoline GmbH. The 510(k) number is K212883.

When did ers2 - ergoline Rehabilitation System receive FDA 510(k) clearance?

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

Who is the listed applicant for ers2 - ergoline Rehabilitation System?

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

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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