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FDA 510(k)

SWISS LITHOBREAKER

K-Number: K123038 · 2013-01-16

ApplicantE.M.S Electro Medical Systems S.A
Decision Date2013-01-16
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SWISS LITHOBREAKER 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 2013-01-16 under 510(k) number K123038. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWISS LITHOBREAKER?

SWISS LITHOBREAKER is a medical device that received FDA 510(k) clearance on 2013-01-16. The listed applicant is E.M.S Electro Medical Systems S.A. The 510(k) number is K123038.

When did SWISS LITHOBREAKER receive FDA 510(k) clearance?

SWISS LITHOBREAKER received FDA 510(k) clearance on 2013-01-16, under 510(k) number K123038.

Who is the listed applicant for SWISS LITHOBREAKER?

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 LITHOBREAKER?

The FDA product code for SWISS LITHOBREAKER is FFK.

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Related Devices (Code: FFK)

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.

K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbHK202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK162119UreTron PF Series ProbeMed-Sonics Corp.

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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