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FDA 510(k)

EHL PULSE GENERATOR

K-Number: K931779 · 1994-02-15

ApplicantPsi Medical Products, Inc.
Decision Date1994-02-15
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EHL PULSE GENERATOR 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 1994-02-15 under 510(k) number K931779. 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 EHL PULSE GENERATOR?

EHL PULSE GENERATOR is a medical device that received FDA 510(k) clearance on 1994-02-15. The listed applicant is Psi Medical Products, Inc.. The 510(k) number is K931779.

When did EHL PULSE GENERATOR receive FDA 510(k) clearance?

EHL PULSE GENERATOR received FDA 510(k) clearance on 1994-02-15, under 510(k) number K931779.

Who is the listed applicant for EHL PULSE GENERATOR?

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 EHL PULSE GENERATOR?

The FDA product code for EHL PULSE GENERATOR is FFK.

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Other records listing Psi Medical Products, Inc. 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.

K915459FLOWMATE HAND PUMPK920410EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROBK926423S/2(TM) STOPCOCKK921415IRRIGATION TUBING SETK921253INSTRUMENT IRRIGATION PUMPK915458URETEROSCOPE

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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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