K863880

Substantially Equivalent

BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.

Applicant: D.R.G. Scientific Industries
Product code: CHL
Advisory panel: Clinical Chemistry
Date received: 1986-10-06
Decision date: 1986-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Boston, 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.