510(k) K823570— CORNING 170 PH/BLOOD GAS ANALYZER

Substantially Equivalent

Corning Medical & Scientific

Clearance details

Applicant
Corning Medical & Scientific
Product code
Code CHL
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CHL

product code CHL
Death
20
Malfunction
999
Total
1,019

Source: openFDA MAUDE database, through . 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.