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FDA 510(k)

AUTOLITH-IEHL

K-Number: K923822 · 1993-01-28

ApplicantNorthgate Technologies, Inc.
Decision Date1993-01-28
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AUTOLITH-IEHL 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 1993-01-28 under 510(k) number K923822. 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 AUTOLITH-IEHL?

AUTOLITH-IEHL is a medical device that received FDA 510(k) clearance on 1993-01-28. The listed applicant is Northgate Technologies, Inc.. The 510(k) number is K923822.

When did AUTOLITH-IEHL receive FDA 510(k) clearance?

AUTOLITH-IEHL received FDA 510(k) clearance on 1993-01-28, under 510(k) number K923822.

Who is the listed applicant for AUTOLITH-IEHL?

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 AUTOLITH-IEHL?

The FDA product code for AUTOLITH-IEHL is FFK.

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Other records listing Northgate Technologies, 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.

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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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