FORAMATRON IV— 510(k) K950857

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K950857 for FORAMATRON IV, Substantially Equivalent on 1995-04-20. Applicant: Parkell, Inc..

Clearance details

Applicant: Parkell, Inc.
Product code: Code LQY
Advisory panel: Unknown
Date received: 1995-02-27
Decision date: 1995-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, 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.