EASYFLOW AIRWAY ADAPTER— 510(k) K935044

Name: FDA 510(k) clearance K935044
Creator: U.S. Food and Drug Administration
Published: 1993-11-18

Substantially Equivalent

Easyflow Airway Systems, Inc.

FDA 510(k) clearance K935044 for EASYFLOW AIRWAY ADAPTER, Substantially Equivalent on 1993-11-18. Applicant: Easyflow Airway Systems, Inc.. Device class: 1.

Clearance details

Applicant: Easyflow Airway Systems, Inc.
Product code: Code CAI
Device class: Class 1
Regulation: 21 CFR 868.5240
Advisory panel: Anesthesiology
Date received: 1993-10-20
Decision date: 1993-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Florida, FL, US

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K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS1995-05-22
K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS1995-05-22

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.