SIGMA 8000 AND SIGMA 8002— 510(k) K942162

Substantially Equivalent

Sigma Intl.

FDA 510(k) clearance K942162 for SIGMA 8000 AND SIGMA 8002, Substantially Equivalent on 1994-10-20. Applicant: Sigma Intl..

Clearance details

Applicant: Sigma Intl.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1994-05-04
Decision date: 1994-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medina, NY, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.