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FDA 510(k)

Swiss LithoClast Trilogy

K-Number: K181997 · 2018-08-30

ApplicantE.M.S Electro Medical Systems S.A
Decision Date2018-08-30
Product CodeFEO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Swiss LithoClast 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 2018-08-30 under 510(k) number K181997. 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 LithoClast Trilogy?

Swiss LithoClast Trilogy is a medical device that received FDA 510(k) clearance on 2018-08-30. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K181997.

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

Swiss LithoClast Trilogy received FDA 510(k) clearance on 2018-08-30, under 510(k) number K181997.

Who is the listed applicant for Swiss LithoClast 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 LithoClast Trilogy?

The FDA product code for Swiss LithoClast 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.

K253254GBT Machine Airflow Prophylaxis MasterK243279DOLORCLAST Focused Shock WavesK230893Swiss LthoClast TrilogyK220538DolorClast RadialK190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneK191079Piezon Built-in Kit, Piezon Built-in Kit LED

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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.

K230893Swiss LthoClast TrilogyE.M.S Electro Medical Systems S.AK182490Swiss 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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