ROMEO(TM) MODEL 1000— 510(k) K872889

Substantially Equivalent

Diva Medical Systems, Inc.

FDA 510(k) clearance K872889 for ROMEO(TM) MODEL 1000, Substantially Equivalent on 1988-04-13. Applicant: Diva Medical Systems, Inc..

Clearance details

Applicant: Diva Medical Systems, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 1987-07-23
Decision date: 1988-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.