FR6000 FLOWMETER— 510(k) K884973

Name: FDA 510(k) clearance K884973
Creator: U.S. Food and Drug Administration
Published: 1989-01-17

Substantially Equivalent

Key Instruments

FDA 510(k) clearance K884973 for FR6000 FLOWMETER, Substantially Equivalent on 1989-01-17. Applicant: Key Instruments. Device class: 1.

Clearance details

Applicant: Key Instruments
Product code: Code CAX
Device class: Class 1
Regulation: 21 CFR 868.2340
Advisory panel: Anesthesiology
Date received: 1988-11-30
Decision date: 1989-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trevose, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAX

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K923781 — MXR-2000 FLOWMETER1993-06-10
K910316 — OHMEDA - LOW FLOW FLOWMETER1991-04-12
K872718 — SERIES D FLOWMETER1987-08-05
K871452 — CLASSIC (TM) 200 OXYGEN FLOWMETER1987-06-22
K862797 — AIRCO 2000 SERIES FLOWMETERS1986-08-08

Adverse events under product code CAX

product code CAX

Death: 3
Other: 1
Total: 4

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.