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FDA 510(k)

ELECTRO MECHANICAL LITHOTRIPTOR

K-Number: K990341 · 1999-07-14

ApplicantNorthgate Technologies, Inc.
Decision Date1999-07-14
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ELECTRO MECHANICAL LITHOTRIPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Northgate Technologies, Inc.. It received FDA 510(k) clearance on 1999-07-14 under 510(k) number K990341. 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 ELECTRO MECHANICAL LITHOTRIPTOR?

ELECTRO MECHANICAL LITHOTRIPTOR is a medical device that received FDA 510(k) clearance on 1999-07-14. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K990341.

When did ELECTRO MECHANICAL LITHOTRIPTOR receive FDA 510(k) clearance?

ELECTRO MECHANICAL LITHOTRIPTOR received FDA 510(k) clearance on 1999-07-14, under 510(k) number K990341.

Who is the listed applicant for ELECTRO MECHANICAL LITHOTRIPTOR?

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

What is the FDA product code for ELECTRO MECHANICAL LITHOTRIPTOR?

The FDA product code for ELECTRO MECHANICAL LITHOTRIPTOR is FFK.

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Other records listing Northgate Technologies, Inc. as applicant

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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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