FLUOROPLUA CARDIAC AND/OR INSTAVIEW— 510(k) K941917

Substantially Equivalent

Fidelity Medical, Inc.

FDA 510(k) clearance K941917 for FLUOROPLUA CARDIAC AND/OR INSTAVIEW, Substantially Equivalent on 1995-02-24. Applicant: Fidelity Medical, Inc..

Clearance details

Applicant: Fidelity Medical, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1994-04-19
Decision date: 1995-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Florham Park, NJ, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.