CARDICARE MODEL MT-301F & MT-301C— 510(k) K032714

Substantially Equivalent

Lumiscope Co., Inc.

FDA 510(k) clearance K032714 for CARDICARE MODEL MT-301F & MT-301C, Substantially Equivalent on 2003-10-22. Applicant: Lumiscope Co., Inc..

Clearance details

Applicant: Lumiscope Co., Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2003-09-02
Decision date: 2003-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Brunswick, NJ, US

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.