GAS-STAT MONITORING SYSTEM— 510(k) K831225

Substantially Equivalent

Cardiovascular Devices, Inc.

FDA 510(k) clearance K831225 for GAS-STAT MONITORING SYSTEM, Substantially Equivalent on 1983-05-27. Applicant: Cardiovascular Devices, Inc..

Clearance details

Applicant: Cardiovascular Devices, Inc.
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 1983-04-15
Decision date: 1983-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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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.