IMPACT 400 #1447X2— 510(k) K833067

Substantially Equivalent

Gilford

FDA 510(k) clearance K833067 for IMPACT 400 #1447X2, Substantially Equivalent on 1983-12-08. Applicant: Gilford.

Clearance details

Applicant: Gilford
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 1983-09-08
Decision date: 1983-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.