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FDA 510(k)

Swiss LthoClast Trilogy

K-Number: K230893 · 2023-10-23

ApplicantE.M.S Electro Medical Systems S.A
Decision Date2023-10-23
Product CodeFEO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Swiss LthoClast Trilogy is the device name listed in this FDA 510(k) record. The listed applicant is E.M.S Electro Medical Systems S.A. It received FDA 510(k) clearance on 2023-10-23 under 510(k) number K230893. The device is classified under product code FEO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Swiss LthoClast Trilogy?

Swiss LthoClast Trilogy is a medical device that received FDA 510(k) clearance on 2023-10-23. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K230893.

When did Swiss LthoClast Trilogy receive FDA 510(k) clearance?

Swiss LthoClast Trilogy received FDA 510(k) clearance on 2023-10-23, under 510(k) number K230893.

Who is the listed applicant for Swiss LthoClast Trilogy?

The FDA 510(k) record lists E.M.S Electro Medical Systems S.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Swiss LthoClast Trilogy?

The FDA product code for Swiss LthoClast Trilogy is FEO.

Other records listing E.M.S Electro Medical Systems S.A 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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Related Devices (Code: FEO)

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.

K182490Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK181997Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK181364Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK173234Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK171024ShockPulse-SE Lithotripsy SystemCybersonics, Inc.

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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