meddevicedb.com FDA Device Reference

ROOT APEX LOCATOR

K972407 Traditional
Decision Date
1997-09-11
Sponsor / Applicant
Toei Electric Co., Ltd.

Technical Specification

510(k) Submission ID K972407
Product Code LQY
Medical Specialty / Panel Unknown
Decision Date 1997-09-11
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

ROOT APEX LOCATOR received FDA 510(k) clearance under submission number K972407, sponsored by Toei Electric Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 1997-09-11.

Classification & Regulation

This clearance is catalogued under FDA product code LQY , within the Unknown review panel as a device.