SIGMA 8000 AND SIGMA 8002— 510(k) K950766

Substantially Equivalent

Sigma Intl. General Medical Apparatus, Inc.

FDA 510(k) clearance K950766 for SIGMA 8000 AND SIGMA 8002, Substantially Equivalent on 1995-03-22. Applicant: Sigma Intl. General Medical Apparatus, Inc..

Clearance details

Applicant: Sigma Intl. General Medical Apparatus, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1995-02-17
Decision date: 1995-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medina, NY, US

Download summary PDF View on FDA.gov ↗

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.