GENOX MODEL CT-1— 510(k) K904639

Substantially Equivalent

Pacific Consolidated Industries

FDA 510(k) clearance K904639 for GENOX MODEL CT-1, Substantially Equivalent on 1991-08-13. Applicant: Pacific Consolidated Industries.

Clearance details

Applicant: Pacific Consolidated Industries
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 1990-10-11
Decision date: 1991-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.