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

Name: FDA 510(k) clearance K833478
Creator: U.S. Food and Drug Administration
Published: 1983-12-16

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. Device class: 1.

Clearance details

Applicant: Anaesthetic Breathing System
Product code: Code CAI
Device class: Class 1
Regulation: 21 CFR 868.5240
Advisory panel: Anesthesiology
Date received: 1983-10-24
Decision date: 1983-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Recent devices under product code CAI

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K954480 — CONDENSATE COLLECTION KIT1995-12-29
K953787 — UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT1995-09-19
K953788 — UNICOR, INC. GAS SAMPLING LINES & CONNECTORS1995-09-19
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.