K861277

Substantially Equivalent

CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000

Applicant: Critichem, Inc.
Product code: DRY
Advisory panel: Cardiovascular
Date received: 1986-04-07
Decision date: 1986-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little Falls, NJ, US

Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.