CLASSIC (TM) 200 OXYGEN FLOWMETER— 510(k) K871452

Name: FDA 510(k) clearance K871452
Creator: U.S. Food and Drug Administration
Published: 1987-06-22

Substantially Equivalent

The Timeter Group

FDA 510(k) clearance K871452 for CLASSIC (TM) 200 OXYGEN FLOWMETER, Substantially Equivalent on 1987-06-22. Applicant: The Timeter Group. Device class: 1.

Clearance details

Applicant: The Timeter Group
Product code: Code CAX
Device class: Class 1
Regulation: 21 CFR 868.2340
Advisory panel: Anesthesiology
Date received: 1987-04-13
Decision date: 1987-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancaster, PA, US

Download summary PDF View on FDA.gov ↗

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K910316 — OHMEDA - LOW FLOW FLOWMETER1991-04-12
K884973 — FR6000 FLOWMETER1989-01-17
K872718 — SERIES D FLOWMETER1987-08-05
K862797 — AIRCO 2000 SERIES FLOWMETERS1986-08-08

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K852374 — OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT181985-07-12
K844556 — KHM 2000 DRIP WATCHER1985-01-14

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.