Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MULTIPLE (APEX LOCATOR), MODEL RCM-7

K-Number: K090925 · 2009-11-23

ApplicantJ. Morita USA, Inc.
Decision Date2009-11-23
Product CodeLQY
DecisionSubstantially Equivalent

Device Summary

MULTIPLE (APEX LOCATOR), MODEL RCM-7 is the device name listed in this FDA 510(k) record. The listed applicant is J. Morita USA, Inc.. It received FDA 510(k) clearance on 2009-11-23 under 510(k) number K090925. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE (APEX LOCATOR), MODEL RCM-7?

MULTIPLE (APEX LOCATOR), MODEL RCM-7 is a medical device that received FDA 510(k) clearance on 2009-11-23. The listed applicant is J. Morita USA, Inc.. The 510(k) number is K090925.

When did MULTIPLE (APEX LOCATOR), MODEL RCM-7 receive FDA 510(k) clearance?

MULTIPLE (APEX LOCATOR), MODEL RCM-7 received FDA 510(k) clearance on 2009-11-23, under 510(k) number K090925.

Who is the listed applicant for MULTIPLE (APEX LOCATOR), MODEL RCM-7?

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

What is the FDA product code for MULTIPLE (APEX LOCATOR), MODEL RCM-7?

The FDA product code for MULTIPLE (APEX LOCATOR), MODEL RCM-7 is LQY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing J. Morita USA, 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.

K213477Root ZX3K2013783D Accuitomo 150NK190509Lubrina 2K173920LS OILK171012Veraview X800K170275Tri Auto ZX2

View all 52 devices →

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

View on FDA Database →

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

↑