FDA 510(k)

Discovery MI Gen2

K-Number: K211846 · 2021-08-20

Decision Date2021-08-20

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Discovery MI Gen2 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K211846. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Discovery MI Gen2?

Discovery MI Gen2 is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K211846.

When did Discovery MI Gen2 receive FDA 510(k) clearance?

Discovery MI Gen2 received FDA 510(k) clearance on 2021-08-20, under 510(k) number K211846.

Who is the listed applicant for Discovery MI Gen2?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Discovery MI Gen2?

The FDA product code for Discovery MI Gen2 is KPS.

Other records listing Ge Medical Systems, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.