K982928

Substantially Equivalent

NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM

Applicant: Radiometer America, Inc.
Product code: CHL
Advisory panel: Clinical Chemistry
Date received: 1998-08-20
Decision date: 1999-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westlake, OH, 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.