MULTIPLE (APEX LOCATOR), MODEL RCM-7— 510(k) K090925

Substantially Equivalent

J. Morita USA, Inc.

FDA 510(k) clearance K090925 for MULTIPLE (APEX LOCATOR), MODEL RCM-7, Substantially Equivalent on 2009-11-23. Applicant: J. Morita USA, Inc..

Clearance details

Applicant: J. Morita USA, Inc.
Product code: Code LQY
Advisory panel: Unknown
Date received: 2009-04-02
Decision date: 2009-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code LQY

product code LQY

Malfunction: 504
Total: 504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.