ANESTHESIA BREATHING CIRCUIT— 510(k) K915452

Substantially Equivalent

Concord/Portex

FDA 510(k) clearance K915452 for ANESTHESIA BREATHING CIRCUIT, Substantially Equivalent on 1992-02-14. Applicant: Concord/Portex.

Clearance details

Applicant: Concord/Portex
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1991-12-05
Decision date: 1992-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

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Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.