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

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.

Clearance details

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

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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.