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FDA 510(k)

SIGNA Premier

K-Number: K193282 · 2020-04-10

ApplicantGe Healthcare (Ge Medical Systems, LLC)
Decision Date2020-04-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIGNA Premier is a medical device manufactured by Ge Healthcare (Ge Medical Systems, LLC). It received FDA 510(k) clearance on 2020-04-10 under approval number K193282. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGNA Premier?

SIGNA Premier is a medical device that received FDA 510(k) clearance on 2020-04-10. It is manufactured by Ge Healthcare (Ge Medical Systems, LLC). The 510(k) number is K193282.

When was SIGNA Premier approved by the FDA?

SIGNA Premier received FDA 510(k) clearance on 2020-04-10, under approval number K193282.

What company makes SIGNA Premier?

SIGNA Premier is manufactured by Ge Healthcare (Ge Medical Systems, LLC).

What is the FDA product code for SIGNA Premier?

The FDA product code for SIGNA Premier is LNH.

Other Devices by Ge Healthcare (Ge Medical Systems, LLC)

K202966SIGNA Architect K213668SIGNA Hero

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Official Source

View on FDA Database →

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

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