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FDA 510(k)

ROOT APEX LOCATOR

K-Number: K972407 · 1997-09-11

ApplicantToei Electric Co., Ltd.
Decision Date1997-09-11
Product CodeLQY
DecisionSubstantially Equivalent

Device Summary

ROOT APEX LOCATOR is the device name listed in this FDA 510(k) record. The listed applicant is Toei Electric Co., Ltd.. It received FDA 510(k) clearance on 1997-09-11 under 510(k) number K972407. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROOT APEX LOCATOR?

ROOT APEX LOCATOR is a medical device that received FDA 510(k) clearance on 1997-09-11. The listed applicant is Toei Electric Co., Ltd.. The 510(k) number is K972407.

When did ROOT APEX LOCATOR receive FDA 510(k) clearance?

ROOT APEX LOCATOR received FDA 510(k) clearance on 1997-09-11, under 510(k) number K972407.

Who is the listed applicant for ROOT APEX LOCATOR?

The FDA 510(k) record lists Toei Electric Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROOT APEX LOCATOR?

The FDA product code for ROOT APEX LOCATOR is LQY.

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Other records listing Toei Electric Co., Ltd. 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: LQY)

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.

K252224Apex Locator (FindPex)Changzhou Sifary Medical Technology Co., Ltd.K242383Apex LocatorShenzhen Rogin Medical Co., Ltd.K242765Electronic Apex Locator (Alpha Apex I)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K231990Apex LocatorCefla S.C.K232717Apex Locator (AL-Pex), Apex Locator (AL-Pex+)Changzhou Haili Medical Co., Ltd.K212178Root Apex LocatorFoshan Coxo Medical Instrument Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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