PRE-CHECK C02 DETECTOR— 510(k) K861398

Substantially Equivalent

Alleghany Intl. Medical Technology

FDA 510(k) clearance K861398 for PRE-CHECK C02 DETECTOR, Substantially Equivalent on 1986-05-06. Applicant: Alleghany Intl. Medical Technology.

Clearance details

Applicant: Alleghany Intl. Medical Technology
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1986-04-15
Decision date: 1986-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Louis, MO, US

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Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.