K946206

Substantially Equivalent

CIBA CORNING 8-- SERIES CO-OXIMETER

Applicant: Ciba Corning Diagnostics Corp.
Product code: CHL
Advisory panel: Clinical Chemistry
Date received: 1994-12-21
Decision date: 1995-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

Adverse events under product code CHL

product code CHL

Death: 20
Malfunction: 999
Total: 1,019

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.