HUMPHREY A.D.E. SYSTEM— 510(k) K833478

Substantially Equivalent

Anaesthetic Breathing System

FDA 510(k) clearance K833478 for HUMPHREY A.D.E. SYSTEM, Substantially Equivalent on 1983-12-16. Applicant: Anaesthetic Breathing System.

Clearance details

Applicant: Anaesthetic Breathing System
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1983-10-24
Decision date: 1983-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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.