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FDA 510(k)

EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB

K-Number: K920410 · 1994-02-14

ApplicantPsi Medical Products, Inc.
Decision Date1994-02-14
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB is the device name listed in this FDA 510(k) record. The listed applicant is Psi Medical Products, Inc.. It received FDA 510(k) clearance on 1994-02-14 under 510(k) number K920410. 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 EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB?

EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB is a medical device that received FDA 510(k) clearance on 1994-02-14. The listed applicant is Psi Medical Products, Inc.. The 510(k) number is K920410.

When did EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB receive FDA 510(k) clearance?

EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB received FDA 510(k) clearance on 1994-02-14, under 510(k) number K920410.

Who is the listed applicant for EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB?

The FDA 510(k) record lists Psi Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB?

The FDA product code for EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB 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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